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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Aspirin; Esomeprazole

Criteria

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