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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Esomeprazole (D961H); Drug: Loxoprofen

• Registration Number: NCT00676117
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-09
• Study First Posted: 2008-05-12
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-11
• Last Update Posted: 2009-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Esomeprazole (D961H)	-
2	Loxoprofen	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Osaka-city, Osaka, Japan