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Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free Combination

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00688428
Collaborator
(none)
84
Enrollment
2
Arms

Study Details

Study Description

Brief Summary

The purpose of this study is to test if fixed dose esomeprazole and ASA capsule is pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
A Phase I, Open-Label, Randomized, Single-Center, 2-Stage Group Sequential Design, 2-Way Crossover Bioequivalence Study Comparing a Fixed-Dose Combination Capsule of Esomeprazole 40mg and Low-Dose Acetylsalicylic Acid (ASA) 325mg With a Free Combination of Esomeprazole Capsule 40mg and Low-Dose ASA
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Apr 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

combination capsule of Esomeprazole 40mg + ASA 325mg

Drug: Esomeprazole 40mg/ASA 325mg
combination capsule, administered as a single oral dose
Other Names:
  • Nexium/Bayer Aspirin

    		•
    Experimental: 2

    Esomeprazole 40 mg capsule and ASA 325 mg tablet

    Drug: Esomeprazole
    40mg capsule, administered as a single dose
    Other Names:
  • Nexium

    • Drug: ASA
    325mg tablet, administered as a single oral dose
    Other Names:
  • Bayer aspirin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Samples for measurement of esomeprazole, ASA, and SA concentrations [Day 1 of each period]

    Secondary Outcome Measures

    1. Fasting blood samples for determination of clinical chemistry and hematology parameters [screening and follow up visit]

    2. urine samples for urinalysis parameters [screening, Period 1, and follow-up visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Body mass index of 19-29kg/m2, inclusive

    • Weight of 50-95kg, inclusive

    • Clinically normal physical findings and laboratory values including hepatitis B, hepatitis C, and HIV, as judged by the Investigator

    Exclusion Criteria:

    • Significant clinical illness within the 2 weeks preceding the first dose of investigational products, as judged by the Investigator

    • History of mental, cardiac, renal, hepatitis, neurological, or significant gastrointestinal disease, as judged by the Investigator

    • Condition which could modify the absorption of the investigational products, as judged by the Investigator

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Jörgen Naesdal, M.D., AstraZeneca
    • Principal Investigator: Christopher Billings ., D.O, Biokinetics Clinical Applications

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00688428
    Other Study ID Numbers:
    • D961FC00002
    First Posted:
    Jun 3, 2008
    Last Update Posted:
    Mar 12, 2009
    Last Verified:
    Mar 1, 2009
    Keywords provided by , ,
    esomeprazole
    upper gi symptoms
    low dose Aspirin treatment
    Additional relevant MeSH terms:
    Aspirin
    Esomeprazole

    Study Results

    No Results Posted as of Mar 12, 2009