Clinical trial NCT01494402: Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence Study
Keywords: Healthy volunteer, Japanese males, homo-EM
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-12-19
Enrollment: 77
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Eligibility 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

Primary outcomes:
measure: Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCτ).
timeFrame: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
measure: Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in term maximum plasma concentration (Cmax,ss)
timeFrame: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
Secondary outcomes:
measure: 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
timeFrame: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
measure: 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.
timeFrame: Pre-entry, Day 5 of treatment period and follow up (5-7 days after last dose)
Other outcomes:
Locations:
city: Hakata
country: Japan
facility: Study site
state: Fukuoka
Study officials:
References: