The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA following repeated administration in healthy male Japanese subjects.

NCT01494402

Conditions

1. Bioequivalence Study

Interventions

1. Drug: D961S
2. Drug: Esomeprazole
3. Drug: Buffered acetylsalicylic acid

A Phase I, Open Label, Randomized, Single Center, 2 Way Crossover Bioequivalence Study Comparing D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) With a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects. --- D961S ---

Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA following repeated administration in healthy male Japanese subjects. --- D961S ---

Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA following repeated administration in healthy male Japanese subjects. --- D961S --- --- D961S ---

Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA following repeated administration in healthy male Japanese subjects. --- D961S --- --- D961S --- --- D961S ---

Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCτ).. --- D961S ---

All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.. Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in term maximum plasma concentration (Cmax,ss). --- D961S ---

All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.. Description of D961S PK profile comparing to esomeprazole and ASA combination in terms of AUC0-t,ss, mean residence time (MRT), time to reach Cmax (tmax,ss) and t1/2,ss of esomeprazole and ASA, and AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss and t1/2,ss of SA. --- D961S ---

No formal comparison will be performed.. Inclusion Criteria: - Healthy Japanese males 20-45 years of age - Classified as homo-EM - Negative for HIV, Hepatitis B, Hepatitis C and syphilis - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg Exclusion Criteria: - Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease - Need for concomitant medication in the study - Past or present NSAIDs induced asthma - History of bleeding diathesis Inclusion Criteria: - Healthy Japanese males 20-45 years of age - Classified as homo-EM - Negative for HIV, Hepatitis B, Hepatitis C and syphilis - Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) - Body weight 50-85 kg Exclusion Criteria: - Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization - Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease - Need for concomitant medication in the study - Past or present NSAIDs induced asthma - History of bleeding diathesis Bioequivalence Study A Phase I, Open label, Randomized, Single center, 2 way Crossover Bioequivalence Study Comparing D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) with a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects --- D961S ---