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

Overview

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).

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2008

Interventions

  • Drug: Esomeprazole (D961H)
    • 20mg
  • Drug: Loxoprofen
    • 60mg tablet

Arms, Groups and Cohorts

  • Experimental: 1
  • Active Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: 5-7 days after the last dose of study medication is given

Secondary Measures

  • 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
    • Time Frame: 5-7 days after the last dose of study medication is given

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Tore Lind – Medical Science Director, AstraZeneca
  • Overall Official(s)
    • Naotsugu Oyama, MD, PhD, Study Director, AstraZeneca
    • Michio Yagi, Principal Investigator, Osaka Pharmacology Clinical Research Hospital

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