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

Bioequivalence Study Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494402
• Other study ID #: D961SC00001
• Status: Completed
• Phase: Phase 1
• First received: December 15, 2011
• Last updated: April 6, 2012
• Start date: January 2012
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bioequivalence Study

Intervention

Drug:
• D961S
Oral gelatine capsule
• Esomeprazole
Oral HPMC capsule
• Buffered acetylsalicylic acid
Tablet

Locations

Country	Name	City	State
Japan	Study site	Hakata	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCt).	All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.	Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6	No
Primary	Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in term maximum plasma concentration (Cmax,ss)	All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.	Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6	No
Secondary	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 AUCt, Cmax,ss, AUC0-t,ss, MRT, tmax,ss and t1/2,ss of SA	All PK variables and plasma concentrations of esomeprazole, ASA and SA at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.	Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6	No
Secondary	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.	Descriptive statistics will be provided for all safety variables, and the analyses will be performed according to the actual treatment. No formal comparison will be performed.	Pre-entry, Day 5 of treatment period and follow up (5-7 days after last dose)	Yes