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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCτ).
Study Overview
Brief 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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
esomeprazole + buffered acetylsalicylic acid
2 way crossover
Intervention: Buffered acetylsalicylic acid (Drug)
D961S
2 way crossover
Intervention: D961S (Drug)
esomeprazole + buffered acetylsalicylic acid
2 way crossover
Intervention: Esomeprazole (Drug)
Outcomes
Primary Outcomes
Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCτ).
Time Frame: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
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)
Time Frame: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.
Secondary Outcomes
- Description of Safety and tolerability profile of esomeprazole in combination with ASA in terms of adverse events, clinical laboratory tests, blood pressure, pulse rate and body temperature.(Pre-entry, Day 5 of treatment period and follow up (5-7 days after last dose))
- 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(Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6)