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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

December 15, 2011
April 6, 2012
January 2012
March 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01494402 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects
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

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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Bioequivalence Study
  • 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
  • Experimental: D961S
    2 way crossover
    Intervention: Drug: D961S
  • Experimental: esomeprazole + buffered acetylsalicylic acid
    2 way crossover
    Interventions:
    • Drug: Esomeprazole
    • Drug: Buffered acetylsalicylic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01494402
D961SC00001
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP