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Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Males

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00676117
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
3
Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic profile of Esomeprazole (D961H) during repeated oral administration with and without co-administration of loxoprofen and the pharmacokinetic profile of loxoprofen during repeated oral administration with and without co-administration of Esomeprazole (D961H).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-Centre, Open, Randomised, Three-Way Cross-Over Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Healthy Male Subjects
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: Esomeprazole (D961H)
20mg
Other Names:
  • Nexium

    		•
    Active Comparator: 2

    Drug: Loxoprofen
    60mg tablet
    Other Names:
  • Loxonin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pharmacokinetic profile of D961H during repeated administration with and without co-administration of loxoprofen and pharmacokinetic profile of loxoprofen during repeated administration with and without co-administration of D961H, assessing plasma conc. [5-7 days after the last dose of study medication is given]

    Secondary Outcome Measures

    1. The safety of D961H with and without coadministration of loxoprofen by assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, urinalysis and haemoccult test), ECG, blood pressure, pulse rate and body temperature [5-7 days after the last dose of study medication is given]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy Japanese male

    • Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)

    • Body weight 50-80 kg

    Exclusion Criteria:

    • Past or present NSAIDs induced asthma, hepatic dysfunction, peptic ulcer or blood disorders

    • Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s) , eg, acute inflammatory disease which requires medical intervention

    • Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Osaka-city Osaka Japan

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Naotsugu Oyama, MD, PhD, AstraZeneca
    • Principal Investigator: Michio Yagi, Osaka Pharmacology Clinical Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00676117
    Other Study ID Numbers:
    • D961HC00007
    First Posted:
    May 12, 2008
    Last Update Posted:
    Mar 12, 2009
    Last Verified:
    Mar 1, 2009
    Keywords provided by , ,
    male
    Japan
    Japanese
    Healthy volunteers
    Additional relevant MeSH terms:
    Loxoprofen
    Esomeprazole

    Study Results

    No Results Posted as of Mar 12, 2009