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 ---

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 ---

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 ---

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 ---

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 ---

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 ---

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 ---

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 ---

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 ---

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 ---

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 ---