Status:
COMPLETED
Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Males
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
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 pharmacokineti...
Eligibility Criteria
Inclusion
- Healthy Japanese male
- Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
- Body weight 50-80 kg
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00676117
Start Date
April 1 2008
End Date
July 1 2008
Last Update
March 12 2009
Active Locations (1)
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1
Research Site
Osaka, Osaka, Japan