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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation D961H

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 11 clinical trials

Clinical Trials


1 A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use

The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers

NCT00542789
Conditions
  1. Gastric Ulcer
  2. Duodenal Ulcer
  3. Rheumatoid Arthritis
  4. Osteoarthritis
  5. Lumbago
Interventions
  1. Drug: Esomeprazole
  2. Drug: Placebo
MeSH:Stomach Ulcer Duodenal Ulcer Ulcer
HPO:Duodenal ulcer Gastric ulcer

Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period. --- D961H ---

Primary Outcomes

Description: The absence of gastric and/or duodenal ulcer throughout the treatment period

Measure: Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period

Time: each visit up to 24 weeks

Secondary Outcomes

Description: The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment

Measure: Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment

Time: up to 4 weeks

Description: The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment

Measure: Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment

Time: up to 12 weeks

2 A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use

The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.

NCT00595517
Conditions
  1. Gastric Ulcer
  2. Duodenal Ulcer
  3. Rheumatoid Arthritis
  4. Osteoarthritis
  5. Lumbago
Interventions
  1. Drug: Esomeprazole 20 mg
MeSH:Stomach Ulcer Duodenal Ulcer Ulcer
HPO:Duodenal ulcer Gastric ulcer

A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use. --- D961H ---

Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs. --- D961H ---

Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs. --- D961H --- --- D961H ---

Primary Outcomes

Measure: Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period

Time: up to 52 weeks

Secondary Outcomes

Measure: Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment

Time: up to 4 weeks after treatment

Measure: Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment

Time: up to 12 weeks after treatment

Measure: Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment

Time: up to 24 weeks after treatment

3 A Single-Centre, Open, Randomised, Three-Way Cross-Over Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Healthy Male Subjects

The purpose of this study is to evaluate the pharmacokinetic profile of Esomeprazole (D961H) during repeated oral administration with and without co-administration of loxoprofen and the pharmacokinetic profile of loxoprofen during repeated oral administration with and without co-administration of Esomeprazole (D961H).

NCT00676117
Conditions
  1. Healthy
Interventions
  1. Drug: Esomeprazole (D961H)
  2. Drug: Loxoprofen

A Single-Centre, Open, Randomised, Three-Way Cross-Over Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Healthy Male Subjects. --- D961H ---

Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Males The purpose of this study is to evaluate the pharmacokinetic profile of Esomeprazole (D961H) during repeated oral administration with and without co-administration of loxoprofen and the pharmacokinetic profile of loxoprofen during repeated oral administration with and without co-administration of Esomeprazole (D961H). --- D961H ---

Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Males The purpose of this study is to evaluate the pharmacokinetic profile of Esomeprazole (D961H) during repeated oral administration with and without co-administration of loxoprofen and the pharmacokinetic profile of loxoprofen during repeated oral administration with and without co-administration of Esomeprazole (D961H). --- D961H --- --- D961H ---

Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Males The purpose of this study is to evaluate the pharmacokinetic profile of Esomeprazole (D961H) during repeated oral administration with and without co-administration of loxoprofen and the pharmacokinetic profile of loxoprofen during repeated oral administration with and without co-administration of Esomeprazole (D961H). --- D961H --- --- D961H --- --- D961H ---

pharmacokinetic profile of D961H during repeated administration with and without co-administration of loxoprofen and pharmacokinetic profile of loxoprofen during repeated administration with and without co-administration of D961H, assessing plasma conc.. null. --- D961H ---

pharmacokinetic profile of D961H during repeated administration with and without co-administration of loxoprofen and pharmacokinetic profile of loxoprofen during repeated administration with and without co-administration of D961H, assessing plasma conc.. null. --- D961H --- --- D961H ---

The safety of D961H with and without coadministration of loxoprofen by assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, urinalysis and haemoccult test), ECG, blood pressure, pulse rate and body temperature. --- D961H ---

Primary Outcomes

Measure: pharmacokinetic profile of D961H during repeated administration with and without co-administration of loxoprofen and pharmacokinetic profile of loxoprofen during repeated administration with and without co-administration of D961H, assessing plasma conc.

Time: 5-7 days after the last dose of study medication is given

Secondary Outcomes

Measure: The safety of D961H with and without coadministration of loxoprofen by assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, urinalysis and haemoccult test), ECG, blood pressure, pulse rate and body temperature

Time: 5-7 days after the last dose of study medication is given

4 Open Label, Randomized, Single Center, 2-way Crossover Bioequivalence Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule 40 mg D961H After Repeated Oral Administration in Japanese Healthy Male Subjects

The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5

NCT00930215
Conditions
  1. Healthy
Interventions
  1. Drug: D961H
  2. Drug: D961H

Open Label, Randomized, Single Center, 2-way Crossover Bioequivalence Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule 40 mg D961H After Repeated Oral Administration in Japanese Healthy Male Subjects. --- D961H ---

Open Label, Randomized, Single Center, 2-way Crossover Bioequivalence Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule 40 mg D961H After Repeated Oral Administration in Japanese Healthy Male Subjects. --- D961H --- --- D961H ---

Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5 Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5. null. --- D961H ---

Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5 Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5. null. --- D961H --- --- D961H ---

Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5 Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5. null. --- D961H --- --- D961H --- --- D961H ---

Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5 Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5. null. --- D961H --- --- D961H --- --- D961H --- --- D961H ---

Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5 Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5. null. --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H ---

Evaluate the PK properties of HPMC capsule of D961H 40 mg following repeated oral doses, by assessment of plasma concentrations, mean residence time, time to maximum plasma concentration and half-life on Day 5. null. --- D961H ---

Evaluate the safety and tolerability of HPMC capsule of D961H 40 mg by assessment of AEs, clinical lab tests, ECG, vital signs.. null. --- D961H ---

Primary Outcomes

Measure: Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5

Time: PK sample at Day 5 of treatment period 1 and treatment period 2

Secondary Outcomes

Measure: Evaluate the PK properties of HPMC capsule of D961H 40 mg following repeated oral doses, by assessment of plasma concentrations, mean residence time, time to maximum plasma concentration and half-life on Day 5

Time: PK sample on Day 5 of treatment period 1 and treatment period 2

Measure: Evaluate the safety and tolerability of HPMC capsule of D961H 40 mg by assessment of AEs, clinical lab tests, ECG, vital signs.

Time: Pre-entry, Day 5 of treatment period 1 and treatment period 2 and follow up (5-7 days after last dose)

5 A Phase III Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for Prevention of Gastric and/or Duodenal Ulcers Associated With Continuous Low-dose Aspirin (LDA) Use

To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers.

NCT01069939
Conditions
  1. Preve
  2. Prevention
Interventions
  1. Drug: Esomeprazole
  2. Drug: Placebo
MeSH:Duodenal Ulcer
HPO:Duodenal ulcer

A Phase III Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for Prevention of Gastric and/or Duodenal Ulcers Associated With Continuous Low-dose Aspirin (LDA) Use. --- D961H ---

Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers. --- D961H ---

Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers. --- D961H --- --- D961H ---

Primary Outcomes

Description: Assessments for occurrence of gastric and/or duodenal ulcers were performed every 12 weeks after randomisation. The numbers of participants with recurrence of gastric and/or duodeal ulcers were analysed every 12 weeks up to 48 weeks.

Measure: Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.

Time: From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)

Secondary Outcomes

Description: Modified Lanza scale attributes the degree of gastric mucosal lesion, graded on a 5 point scale (0=No hemorrhage, no erosion, 1=One hemorrhage or one erosions, 2=2-10 hemorrhages or erosions, 3=11-25 hemorrhages or erosions, 4=More than 25 hemorrhages or erosions, or ulcer). Higher scores indicate greater severity of gastric mucosal lesion.

Measure: Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48

Time: Up to 48 weeks (Baseline to last measurement)

Description: Endoscopy was conducted at 12, 24, 36 and 48 weeks after randomisation. At the endoscopy, participants was evaluated whether they have reflux esophagitis or not.

Measure: Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.

Time: 12, 24, 36 and 48 weeks

Description: The severity of epigastric pain at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".

Measure: Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48

Time: Up to 48 weeks (Baseline to last measurement)

Description: The severity of heartburn at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".

Measure: Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.

Time: Up to 48 weeks (Baseline to last measurement)

Description: The severity of anorexia at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".

Measure: Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48

Time: Up to 48 weeks (Baseline to last measurement)

Description: The severity of abdomen enlarged feeling at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".

Measure: Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week

Time: Up to 48 weeks (Baseline to last measurement)

Description: The severity of Nausea and/or Vomiting at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".

Measure: Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48

Time: Up to 48 weeks (Baseline to last measurement)

Description: The severity of Discomfort in the stomach at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".

Measure: Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48

Time: Up to 48 weeks (Baseline to last measurement)

Description: Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.

Measure: Number of Participants With Adverse Events

Time: Up to 70 weeks at the longest

6 A Randomised, Single Blind, Two-way Cross-over, Single-centre Study to Assess the Pharmacodynamics (Intragastric pH) and Pharmacokinetics After Repeated Oral Administration of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects

The purpose of this study is to assess the pharmacodynamics (intragastric pH) after repeated oral administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects who are classified by the genotype of CYP2C19 by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on day 5.

NCT01159145
Conditions
  1. Pharmacodynamics Study
Interventions
  1. Drug: D961H
  2. Drug: Omeprazole

A Randomised, Single Blind, Two-way Cross-over, Single-centre Study to Assess the Pharmacodynamics (Intragastric pH) and Pharmacokinetics After Repeated Oral Administration of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects. --- D961H ---

Study to Assess the Pharmacodynamics/Pharmacokinetics After Repeated Dosing of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects The purpose of this study is to assess the pharmacodynamics (intragastric pH) after repeated oral administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects who are classified by the genotype of CYP2C19 by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on day 5. --- D961H ---

Study to Assess the Pharmacodynamics/Pharmacokinetics After Repeated Dosing of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects The purpose of this study is to assess the pharmacodynamics (intragastric pH) after repeated oral administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects who are classified by the genotype of CYP2C19 by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on day 5. --- D961H --- --- D961H ---

To assess the pharmacodynamics (intragastric pH) after repeated administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects by the assessment of percentage of time with intragastric pH>4.. null. --- D961H ---

To assess the pharmacodynamics (intragastric pH) after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median intragastric pH.. null. --- D961H ---

To assess the pharmacokinetics after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of plasma concentrations and AUCt, AUCt, Css,max, tmax, and t1/2 for D961H and omeprazole after dose on day 5.. null. --- D961H ---

To assess the pharmacokinetics after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of plasma concentrations and AUCt, AUCt, Css,max, tmax, and t1/2 for D961H and omeprazole after dose on day 5.. null. --- D961H --- --- D961H ---

To assess the safety and the tolerability after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of adverse events, laboratory variables, pulse rate, blood pressure, body temperature and 12-lead ECG. --- D961H ---

Primary Outcomes

Measure: To assess the pharmacodynamics (intragastric pH) after repeated administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects by the assessment of percentage of time with intragastric pH>4.

Time: A range of 24 hrs

Secondary Outcomes

Measure: To assess the pharmacodynamics (intragastric pH) after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median intragastric pH.

Time: A range of 24 hrs

Measure: To assess the pharmacokinetics after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of plasma concentrations and AUCt, AUCt, Css,max, tmax, and t1/2 for D961H and omeprazole after dose on day 5.

Time: A range of 24 hours

Measure: To assess the safety and the tolerability after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of adverse events, laboratory variables, pulse rate, blood pressure, body temperature and 12-lead ECG

Time: Until last visit, 5-7 days after last dose

7 A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects.

NCT01595425
Conditions
  1. Bioequivalence Study
Interventions
  1. Drug: D961H Sachet 20 mg
  2. Drug: D961H HPMC capsule 20 mg

A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects. --- D961H ---

A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects. --- D961H --- --- D961H ---

Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects. --- D961H ---

Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects. --- D961H --- --- D961H ---

Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects. --- D961H --- --- D961H --- --- D961H ---

Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects. --- D961H --- --- D961H --- --- D961H --- --- D961H ---

AUCτ and Cmax,ss of D961H. --- D961H ---

Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2.. AUC0-t,ss-Area under plasma concentration time curve from zero to time of the last measurable concentration at steady state MRT- Mean residence time tmax,ss -time of maximum concentration at steady state t½ -Terminal half-life. --- D961H ---

Safety and tolerability of a D961H in terms of clinical laboratory tests, blood pressure, pulse rate and body temperature.. null. --- D961H ---

Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures 2. Japanese healthy male subjects aged 20 to 45 years of age 3. Body Mass Index 19-27 kg/m2 and body weight 50-85 kg 4. Clinically normal findings 5. Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19 Exclusion Criteria: 1. Significant clinical illness 2. Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease 3. Clinical significant condition which could modify the absorption of the investigational product 4. Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures 2. Japanese healthy male subjects aged 20 to 45 years of age 3. Body Mass Index 19-27 kg/m2 and body weight 50-85 kg 4. Clinically normal findings 5. Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19 Exclusion Criteria: 1. Significant clinical illness 2. Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease 3. Clinical significant condition which could modify the absorption of the investigational product 4. Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention Bioequivalence Study A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects --- D961H ---

Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures 2. Japanese healthy male subjects aged 20 to 45 years of age 3. Body Mass Index 19-27 kg/m2 and body weight 50-85 kg 4. Clinically normal findings 5. Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19 Exclusion Criteria: 1. Significant clinical illness 2. Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease 3. Clinical significant condition which could modify the absorption of the investigational product 4. Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures 2. Japanese healthy male subjects aged 20 to 45 years of age 3. Body Mass Index 19-27 kg/m2 and body weight 50-85 kg 4. Clinically normal findings 5. Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19 Exclusion Criteria: 1. Significant clinical illness 2. Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease 3. Clinical significant condition which could modify the absorption of the investigational product 4. Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention Bioequivalence Study A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects --- D961H --- --- D961H ---

Primary Outcomes

Description: AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration Cmax,ss - maximum concentration at steady state

Measure: AUCτ and Cmax,ss of D961H

Time: Day 5

Secondary Outcomes

Description: AUC0-t,ss-Area under plasma concentration time curve from zero to time of the last measurable concentration at steady state MRT- Mean residence time tmax,ss -time of maximum concentration at steady state t½ -Terminal half-life

Measure: Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2.

Time: Day 5

Measure: Safety and tolerability of a D961H in terms of clinical laboratory tests, blood pressure, pulse rate and body temperature.

Time: Up to 5 to 7 days after the last dose.

Measure: Number of participants with adverse events.

Time: Up to 5 to 7 days after the last dose.

8 A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Twice Daily Oral Administration and D961H 20 mg Once Daily Oral Administration in Patients With Refractory Reflux Esophagitis

This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification

NCT01669811
Conditions
  1. Refractory Reflux Esophagitis
Interventions
  1. Drug: Esomeprazole (D961H) twice daily
  2. Drug: Esomeprazole (D961H) once daily
MeSH:Gastroesophageal Reflux Esophagitis Esophagitis, Peptic
HPO:Esophagitis Gastroesophageal reflux

A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Twice Daily Oral Administration and D961H 20 mg Once Daily Oral Administration in Patients With Refractory Reflux Esophagitis. --- D961H ---

A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Twice Daily Oral Administration and D961H 20 mg Once Daily Oral Administration in Patients With Refractory Reflux Esophagitis. --- D961H --- --- D961H ---

Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus) This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification. --- D961H ---

Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus) This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification. --- D961H --- --- D961H ---

Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus) This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification. --- D961H --- --- D961H --- --- D961H ---

Refractory Reflux Esophagitis Gastroesophageal Reflux Esophagitis Esophagitis, Peptic A multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of D961H 20 mg twice daily oral administration and D961H 20 mg once daily oral administration in patients with refractory reflux esophagitis --- D961H ---

Refractory Reflux Esophagitis Gastroesophageal Reflux Esophagitis Esophagitis, Peptic A multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of D961H 20 mg twice daily oral administration and D961H 20 mg once daily oral administration in patients with refractory reflux esophagitis --- D961H --- --- D961H ---

Primary Outcomes

Description: Percentage of participants with healing of reflux esophagitis (RE) who were graded "O" (No RE) at Week 8 out of participants who were graded "A" (least severe) to "D" (most severe) at baseline according to Los Angeles classification

Measure: Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification

Time: 8 Weeks

Secondary Outcomes

Description: Percentage of participants with healing of reflux esophagitis (RE) who were graded "O" (No RE) at Week 4 out of participants who were graded "A" (least severe) to "D" (most severe) at baseline according to Los Angeles classification

Measure: Percentage of Participants With Healing of RE Who Were Graded "O" at Week 4 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification

Time: 4 Weeks

Description: Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -heartburn at Week 4 (on Day 29) based on the Kaplan-Meier method.

Measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4

Time: 4 Weeks

Description: Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -acid regurgitation at Week 4 (on Day 29) based on the Kaplan-Meier method.

Measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4

Time: 4 Weeks

Description: Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -abdominal pain at Week 4 (on Day 29) based on the Kaplan-Meier method.

Measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4

Time: 4 Weeks

Description: Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -difficulty of swallowing at Week 4 (on Day 29) based on the Kaplan-Meier method.

Measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4

Time: 4 Weeks

Description: Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -sleep disturbance at Week 4 (on Day 29) based on the Kaplan-Meier method.

Measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4

Time: 4 Weeks

9 An Open Label, Randomised, Single Center, 2 Way Crossover Study to Assess Bioequivalence Between a Commercial HPMC Capsule of D961H 20 mg and a Pellets Based Sachet Formulation of D961H 20 mg by Pharmacodynamics (Intragastric pH) After Once-daily Repeated Oral Administration in Japanese Healthy Male Subjects

The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>4. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.

NCT01964131
Conditions
  1. Gastric Ulcer
  2. Duodenal Ulcer
  3. Anastomotic Ulcer
  4. Reflux Esophagitis
  5. Etc.
Interventions
  1. Drug: D961H sachet 20 mg
  2. Drug: D961H HPMC capsule 20 mg
MeSH:Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic Ulcer
HPO:Duodenal ulcer Esophagitis Gastric ulcer

An Open Label, Randomised, Single Center, 2 Way Crossover Study to Assess Bioequivalence Between a Commercial HPMC Capsule of D961H 20 mg and a Pellets Based Sachet Formulation of D961H 20 mg by Pharmacodynamics (Intragastric pH) After Once-daily Repeated Oral Administration in Japanese Healthy Male Subjects. --- D961H ---

An Open Label, Randomised, Single Center, 2 Way Crossover Study to Assess Bioequivalence Between a Commercial HPMC Capsule of D961H 20 mg and a Pellets Based Sachet Formulation of D961H 20 mg by Pharmacodynamics (Intragastric pH) After Once-daily Repeated Oral Administration in Japanese Healthy Male Subjects. --- D961H --- --- D961H ---

BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>4. --- D961H ---

BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>4. --- D961H --- --- D961H ---

BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>4. --- D961H --- --- D961H --- --- D961H ---

To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH. --- D961H ---

To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH. --- D961H --- --- D961H ---

To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg. --- D961H ---

To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg. --- D961H --- --- D961H ---

To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg. --- D961H ---

To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg. --- D961H --- --- D961H ---

Description of whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg. --- D961H ---

Description of whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg. --- D961H --- --- D961H ---

To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5.. Description to compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH. --- D961H ---

To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5.. Description to compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH. --- D961H --- --- D961H ---

To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5.. Description to compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH. --- D961H --- --- D961H --- --- D961H ---

To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5.. Description to compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH. --- D961H --- --- D961H --- --- D961H --- --- D961H ---

To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5. Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.. Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.. Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Gastric Ulcer Duodenal Ulcer Anastomotic Ulcer Reflux Esophagitis Etc. --- D961H ---

To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5. Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.. Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.. Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Gastric Ulcer Duodenal Ulcer Anastomotic Ulcer Reflux Esophagitis Etc. --- D961H --- --- D961H ---

To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5. Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.. Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.. Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Gastric Ulcer Duodenal Ulcer Anastomotic Ulcer Reflux Esophagitis Etc. --- D961H --- --- D961H --- --- D961H ---

To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5. Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.. Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.. Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Gastric Ulcer Duodenal Ulcer Anastomotic Ulcer Reflux Esophagitis Etc. --- D961H --- --- D961H --- --- D961H --- --- D961H ---

To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5. Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.. Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.. Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Gastric Ulcer Duodenal Ulcer Anastomotic Ulcer Reflux Esophagitis Etc. --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H ---

To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5. Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.. Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.. Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Gastric Ulcer Duodenal Ulcer Anastomotic Ulcer Reflux Esophagitis Etc. --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H ---

To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5. Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.. Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.. Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Gastric Ulcer Duodenal Ulcer Anastomotic Ulcer Reflux Esophagitis Etc. --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H ---

To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5. Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.. Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.. Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Gastric Ulcer Duodenal Ulcer Anastomotic Ulcer Reflux Esophagitis Etc. --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H ---

To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5. Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.. Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.. Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Gastric Ulcer Duodenal Ulcer Anastomotic Ulcer Reflux Esophagitis Etc. --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H ---

To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5. Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.. Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.. Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures - Healthy Japanese male subjects between 20 and 45 years of age - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg - Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis - Clinically normal findings at the enrolment medical examination, as judged by the investigator(s) - Homo-EM according to the genotype of CYP2C19 - Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording - Helicobacter pylori negative has been known by urea breath test as the volunteer panel data Exclusion Criteria: - Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction - Past or present drug addiction or alcohol abuse - Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention - Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use) - Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach - Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation) - Need for concomitant medication in the study - Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor - Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1 - Administration of any investigational product within 4 months preceding the pre-entry visit - Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site) - Clinical judgment by the investigator(s) that the subject should not participate in the study Gastric Ulcer Duodenal Ulcer Anastomotic Ulcer Reflux Esophagitis Etc. --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H ---

Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic Ulcer The purpose of this study is; To investigate whether a pellets based sachet formulation of D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20 mg (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5 To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature. --- D961H ---

Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic Ulcer The purpose of this study is; To investigate whether a pellets based sachet formulation of D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20 mg (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5 To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature. --- D961H --- --- D961H ---

Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic Ulcer The purpose of this study is; To investigate whether a pellets based sachet formulation of D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20 mg (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5 To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature. --- D961H --- --- D961H --- --- D961H ---

Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic Ulcer The purpose of this study is; To investigate whether a pellets based sachet formulation of D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20 mg (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5 To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature. --- D961H --- --- D961H --- --- D961H --- --- D961H ---

Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic Ulcer The purpose of this study is; To investigate whether a pellets based sachet formulation of D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20 mg (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5 To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature. --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H ---

Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic Ulcer The purpose of this study is; To investigate whether a pellets based sachet formulation of D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20 mg (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5 To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature. --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H ---

Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic Ulcer The purpose of this study is; To investigate whether a pellets based sachet formulation of D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20 mg (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5 To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature. --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H ---

Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic Ulcer The purpose of this study is; To investigate whether a pellets based sachet formulation of D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20 mg (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5 To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature. --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H ---

Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic Ulcer The purpose of this study is; To investigate whether a pellets based sachet formulation of D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20 mg (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5 To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature. --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H ---

Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic Ulcer The purpose of this study is; To investigate whether a pellets based sachet formulation of D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20 mg (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5 To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature. --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H --- --- D961H ---

Primary Outcomes

Description: To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5.

Measure: Description of whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg

Time: 27 days

Secondary Outcomes

Description: To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5

Measure: Description to compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH

Time: 27 days

Description: To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.

Measure: Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.

Time: 27 days

Description: To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.

Measure: Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.

Time: 34 days

10 An Open-label, Parallel-group, Multi-centre, Phase I/III Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10 mg and D961H 20 mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases

The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome.

NCT02153398
Conditions
  1. Gastric Ulcer (GU)
  2. Duodenal Ulcer (DU)
  3. Anastomotic Ulcer (AU)
  4. Non-erosive Reflux Esophagitis Disease (NERD)
  5. Reflux Esophagitis (RE)
  6. Zollinger-Ellison Syndrome
Interventions
  1. Drug: D961H sachet 10 mg
  2. Drug: D961H capsule 10mg
  3. Drug: D961H capsule 20 mg
MeSH:Zollinger-Ellison Syndrome Gastrinoma Gastroesophageal Reflux Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic Ulcer
HPO:Duodenal ulcer Esophagitis Gastric ulcer Gastroesophageal reflux Zollinger-Ellison syndrome

An Open-label, Parallel-group, Multi-centre, Phase I/III Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10 mg and D961H 20 mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases. --- D961H ---

An Open-label, Parallel-group, Multi-centre, Phase I/III Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10 mg and D961H 20 mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases. --- D961H --- --- D961H ---

A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome. --- D961H ---

A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome. --- D961H --- --- D961H ---

A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome. --- D961H --- --- D961H --- --- D961H ---

Primary Outcomes

Description: The disappearance of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of heartburn were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.

Measure: Disappearance of Heartburn at Week 8 by Patient Diaries

Time: 8 weeks

Description: The disappearance of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of epigastric pain were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.

Measure: Disappearance of Epigastric Pain at Week 8 by Patient Diaries

Time: 8 weeks

Description: The disappearance of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of upper abdominal discomfort were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.

Measure: Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries

Time: 8 weeks

Description: The disappearance of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of regurgitation were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.

Measure: Disappearance of Regurgitation at Week 8 by Patient Diaries

Time: 8 weeks

Description: The aggravation of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of heartburn were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.

Measure: Aggravation of Heartburn at Week 8 by Patient Diaries

Time: 8 weeks

Description: The aggravation of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of epigastric pain were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.

Measure: Aggravation of Epigastric Pain at Week 8 by Patient Diaries

Time: 8 weeks

Description: The aggravation of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of upper abdominal discomfort were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.

Measure: Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries

Time: 8 weeks

Description: The aggravation of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of regurgitation were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.

Measure: Aggravation of Regurgitation at Week 8 by Patient Diaries

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of heartburn were defined as those who had a heartburn at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.

Measure: Disappearance of Heartburn at Week 8 by Investigators

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of epigastric pain were defined as those who had an epigastric pain at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.

Measure: Disappearance of Epigastric Pain at Week 8 by Investigators

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of upper abdominal discomfort were defined as those who had an upper abdominal discomfort at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.

Measure: Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of regurgitation were defined as those who had a regurgitation at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.

Measure: Disappearance of Regurgitation at Week 8 by Investigators

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of heartburn were defined as those who had no heartburn at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.

Measure: Aggravation of Heartburn at Week 8 by Investigators

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of epigastric pain were defined as those who had no epigastric pain at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.

Measure: Aggravation of Epigastric Pain at Week 8 by Investigators

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of upper abdominal discomfort were defined as those who had no upper abdominal discomfort at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.

Measure: Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of regurgitation were defined as those who had no regurgitation at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.

Measure: Aggravation of Regurgitation at Week 8 by Investigators

Time: 8 weeks

Secondary Outcomes

Measure: Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose

Time: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Measure: AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose

Time: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Measure: Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose

Time: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Measure: Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose

Time: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Measure: Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose

Time: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Measure: Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose

Time: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Measure: Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose

Time: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

11 An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients With Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated With Non-steroidal Anti-inflammatory Drugs or Low-dose Aspirin

This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H in Japanese paediatric patients treated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy who have a documented medical history of gastric ulcer or duodenal ulcer diagnosis. Doses of D961H in this study is set for the 2 groups (weight more than equal 10 kg to less than 20 kg and weight more than equal 20 kg) in the maintenance therapy for healed reflux esophagitis group and the prevention of gastric ulcer or duodenal ulcer recurrence by non-steroidal anti-inflammatory drugs or low-dose aspirin therapy group, Primary endpoints are evaluated at week 32. Further, this study is designed to evaluate the long term efficacy and safety of D961H for a maximum of 52 weeks, in consideration of the medical needs for long term proton pump inhibitor treatment. Patient can continue study treatment up to 52 weeks, if they want.

NCT03553563
Conditions
  1. Reflux Esophagitis
  2. Gastric Ulcer
  3. Duodenal Ulcer
Interventions
  1. Drug: D961H capsule 10mg
  2. Drug: D961H sachet 10mg
MeSH:Gastroesophageal Reflux Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic Ulcer
HPO:Duodenal ulcer Esophagitis Gastric ulcer Gastroesophageal reflux

An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients With Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated With Non-steroidal Anti-inflammatory Drugs or Low-dose Aspirin. --- D961H ---

A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H in Japanese paediatric patients treated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy who have a documented medical history of gastric ulcer or duodenal ulcer diagnosis. --- D961H ---

A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H in Japanese paediatric patients treated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy who have a documented medical history of gastric ulcer or duodenal ulcer diagnosis. --- D961H --- --- D961H ---

A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H in Japanese paediatric patients treated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy who have a documented medical history of gastric ulcer or duodenal ulcer diagnosis. --- D961H --- --- D961H --- --- D961H ---

Doses of D961H in this study is set for the 2 groups (weight more than equal 10 kg to less than 20 kg and weight more than equal 20 kg) in the maintenance therapy for healed reflux esophagitis group and the prevention of gastric ulcer or duodenal ulcer recurrence by non-steroidal anti-inflammatory drugs or low-dose aspirin therapy group, Primary endpoints are evaluated at week 32. --- D961H ---

Further, this study is designed to evaluate the long term efficacy and safety of D961H for a maximum of 52 weeks, in consideration of the medical needs for long term proton pump inhibitor treatment. --- D961H ---

Number of Subjects Maintenance therapy for healed reflux esophagitis study part: - Group1:aged 1 to 14 years (weight more than equal 10 kg to less than 20 kg ), Maintenance phase, n=5 to 10 - Group2:aged 1 to 14 years (weight more than equal 20 kg), Maintenance phase, n=10 to 20 Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: - Group3:aged 1 to 14 years (weight more than equal 10 kg to less than 20 kg), n=5 to 10 at Week 0 - Group4:aged 1 to 14 years (weight more than equal 20 kg), n=10 to 20 at Week 0 All subjects have a D961H administration for 32 or 52 weeks. --- D961H ---

Primary Outcomes

Description: Maintenance therapy for healed reflux esophagitis study part: Presence/absence of reflux esophagitis relapse from 8 to 32 weeks for all subjects by assessment of the composite endpoint (reflux esophagitis -related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.

Measure: Presence/absence of reflux esophagitis relapse

Time: 8 to 32 weeks

Description: Maintenance therapy for healed reflux esophagitis study part: Safety from 8 to 32 weeks for all subjects.

Measure: Adverse events during reflux esophagitis maintenance therapy

Time: 8 to 32 weeks

Description: Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 32 weeks for all subjects by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.

Measure: Presence/absence of gastric ulcer or duodenal ulcer recurrence

Time: 0 to 32 weeks

Description: Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Safety from 0 to 32 weeks for all subjects.

Measure: Adverse events during gastric ulcer or duodenal ulcer recurrence prevention therapy

Time: 0 to 32 weeks

Secondary Outcomes

Description: Presence/absence of reflux esophagitis relapse from 8 to 52 weeks for subjects who continued the study treatment after Week 32 by assessment of the composite endpoint (reflux esophagitis-related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.

Measure: Presence/absence of reflux esophagitis relapse

Time: 8 to 52 weeks

Description: Maintenance therapy for healed reflux esophagitis study part: Safety from 8 to 52 weeks for subjects who continued the study treatment after Week 32.

Measure: Adverse events during reflux esophagitis maintenance therapy

Time: 8 to 52 weeks

Description: Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 52 weeks for subjects who continued the study treatment after Week 32 by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.

Measure: Presence/absence of gastric ulcer or duodenal ulcer recurrence

Time: 0 to 52 weeks

Description: Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Safety from 0 to 52 weeks for subjects who continued the study treatment after Week 32.

Measure: Adverse events during gastric ulcer or duodenal ulcer recurrence prevention therapy

Time: 0 to 52 weeks


HPO Nodes


HP:0002020: Gastroesophageal reflux
Genes 453
ZIC2 HLA-DQA1 TERT KCNA2 SLC1A4 POGZ COL7A1 NONO NRXN1 NODAL COL5A1 SHANK3 PGM3 LIMK1 SCN8A ERCC8 ORC6 CTHRC1 FOXG1 EXT2 COL7A1 EEF1A2 RHBDF2 SIX3 SYT1 ACTL6B GP1BB FGFR3 TYMP DSP MLXIPL HLA-DRB1 KAT6A CHMP1A SEC24C SYNJ1 SYT1 CPLX1 CAMK2B PAK1 LRP5 RNF125 STAG1 WWOX NSD2 SNRPB FBXL4 SLC25A24 DISP1 GAS1 FOXH1 MECP2 ELN MAGEL2 OCRL PSPH JMJD1C UFD1 CREBBP CCR6 HNRNPH2 ASXL1 FCSK DLL1 SIX3 ORC1 SEC31A ASPA GTF2I NECAP1 NUP62 NSD1 GABRB2 FOXG1 FOXH1 GABRA2 MUC5B DDOST CDON ADAR TCF4 NALCN TRAK1 GAS1 SCN3A STAG2 COL13A1 SLC46A1 TMTC3 COL5A2 SPOP CYFIP2 PIK3CD NODAL NUP214 BRAF TRIP4 CACNA1B VAMP1 KMT2A SHH DISP1 RAD21 MECP2 TRMT10C GLI2 COL1A1 SEC23A HIVEP2 ITCH RERE BLM DISP1 TSPYL1 TWNK SLC13A5 FGF8 PSAP GABRA5 TDGF1 SLC2A10 ATAD1 SLC19A2 GLI2 FGF8 NIPBL TRAPPC12 TWIST1 MECP2 FGFR1 HLA-DRB1 CREBBP GNAS TBX4 SLC9A6 LETM1 NIPBL SRPX2 ATN1 CDKL5 RPL10 FMR1 CDON GRIN2D STAG2 NEDD4L DNM1 SIX3 RETREG1 RAI1 LBR ATP11A SAMD9 CAMTA1 RAI1 LAMA2 DDOST PHGDH ORC4 RERE ALMS1 ZIC2 HDAC8 ATRX KCNQ2 PUF60 LONP1 GABRG2 RPL10 TOP3A FGF8 ABCA3 DPP9 CSPP1 SFTPA1 SHH TSPYL1 ARV1 STXBP1 SON CNTNAP2 RET STAG2 ABCD4 PCGF2 KCNQ3 NODAL SLC1A2 RRM2B SKI NOS1 PTCH1 ZIC2 SMC1A CLTC CTCF GAS1 CNTNAP1 STAC3 PIGN TCF4 NTRK2 KCNB1 TIMM22 NEXMIF DYRK1A ASCC1 KNSTRN FLCN CDON TECPR2 MEIS2 POLG CDKN1A HCN1 IRF5 MSL3 CCN2 CAV1 PTCH1 GMNN MAP3K7 GLI2 SLC6A3 CCDC47 TCF4 SLC25A1 FARSB AARS1 PACS1 RPL10 CHD7 SLC25A4 CENPT DHCR7 SCN9A COL13A1 PIGN SMC1A FAM13A CHAT NPHS1 COG7 DYRK1A SH2B1 SLC18A3 CDKN1B SMC1A MEN1 ASCL1 MRPS34 KIF1A FBN1 ADNP NRXN1 CCR6 CDK19 SETD2 AMER1 RREB1 SLC35A2 ARVCF ATRX NEPRO MSR1 CLIP2 TBX1 PIGT SETD5 POGZ SYNGAP1 PPP3CA GEMIN4 ERMARD SFTPC KIAA0586 KLHL7 PRKCSH BAZ1B ZSWIM6 WHCR MAP3K7 IRF5 RRM2B AFF4 RFC2 SIX3 AP3B2 TDGF1 EBF3 KAT6B CACNA1A CDKN2C SLC6A3 USP7 ATRX FGF12 SEMA3E SHANK3 SFTPA2 SLC35A2 CDON FLNA ADGRG1 KMT2A RAD21 ALDH18A1 CCDC22 MAGEL2 TBC1D24 PARN MAP1B PARS2 PPM1D MED12L GLRA1 RAI1 CAV1 ZIC2 PI4KA AFF4 ARID2 HDAC8 CDC6 SMG9 ALDH18A1 NONO FOXH1 EXT2 MYMK GPHN UBA5 ARF1 FGF8 PHOX2B SHROOM4 ATRX GABRD POLG2 EP300 KCNAB2 TGIF1 CRLF1 WAC POLG2 PIGN TERT DHCR7 ADAMTS2 PTCH1 HRAS ARFGEF2 AGRN TDGF1 ERCC6 SNAP25 SHH WNK1 ELP1 LTBP4 ASXL1 GLI2 MID1 SKI CLCN4 CREBBP DHDDS GAS1 FOXG1 WASHC5 GALC NEXMIF RERE TFAP2A COMT TBX1 TGIF1 FLNA GTF2IRD1 SLC5A7 NUS1 KCNA2 NFIX DEAF1 SKI PTCH1 UBA5 DALRD3 ADAT3 YWHAG SMC3 FOXH1 STAG1 TAF1 FLII NALCN CNKSR2 TGIF1 SALL1 SMC3 RTEL1 STN1 APC2 PIEZO2 PIEZO1 SZT2 SEC63 SLC6A5 GLRB TDGF1 DLL1 PORCN CCN2 SHH TGIF1 EHMT1 CTBP1 ATP7A FGFR1 MYO9A FGFRL1 CHRNA3 HLA-DQB1 POLG MMP1 ELN WDR26 CHAMP1 SOX5 ATP6V1A ELP1 POLR2A NODAL SYT2 DDC MCEE ATP6 TBL2 DLL1 ARNT2 MED12 CDKN2B SMC1A HIRA TERC IQSEC2 KIAA0319L DLL1 SSR4 GNB5 PRDM16 PYCR1 DISP1
Protein Mutations 1
D961H
SNP 0