Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects

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

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.

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

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