S(+)-Ibuprofen Effects on Asprin Treated Volunteers

Phase 1

Completed

• Conditions: Drug Interactions

• Registration Number: NCT00442585
• Lead Sponsor: Gebro Pharma GmbH

Brief Summary

The purpose of this clinical trial is to determine whether S(+)-ibuprofen affect the platelet inhibition under steady state acetylsalicylic acid conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-03-01
• Study First Submitted QC: 2007-03-01
• Study First Posted: 2007-03-02
• Study Completion: 2007-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-12
• Last Update Posted: 2012-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Healthy caucasian volunteer
• Must be able to swallow tablets

Exclusion Criteria

• Underlying diseases
• Ulcus pepticum in history
• Abuse of alcoholic beverages (40g/d)
• Hypersensitivity to investigational medicinal products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of inhibition of TxB2 after 1, 3, 7 and 10 days

Secondary Outcome Measures

Name	Time	Method
percentage of subjects with >90% inhibition of TxB2, CEPI-CT and CADP-CT measured by PAF100,
prostacyclin metabolite

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University Vienna; 🇦🇹 Vienna, Austria