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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01494402

First received: December 15, 2011

Last updated: April 6, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 15, 2011
Last Updated Date	April 6, 2012
Start Date ^ICMJE	January 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 16, 2011)	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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01494402 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 16, 2011)	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 [ Time Frame: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6 ] [ Designated as safety issue: No ] 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. 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. [ Time Frame: Pre-entry, Day 5 of treatment period and follow up (5-7 days after last dose) ] [ Designated as safety issue: Yes ] 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects
Official Title ^ICMJE	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
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 Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Bioequivalence Study
Intervention ^ICMJE	Drug: D961S Oral gelatine capsule Drug: Esomeprazole Oral HPMC capsule Other Name: Nexium® capsule 20 mg Drug: Buffered acetylsalicylic acid Tablet Other Name: Bufferin Combination Tablet A81
Study Arm (s)	Experimental: D961S 2 way crossover Intervention: Drug: D961S Experimental: esomeprazole + buffered acetylsalicylic acid 2 way crossover Interventions: Drug: Esomeprazole Drug: Buffered acetylsalicylic acid
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	77
Completion Date	March 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	20 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01494402
Other Study ID Numbers ^ICMJE	D961SC00001
Has Data Monitoring Committee	Not Provided
Responsible Party	AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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