S(+)-Ibuprofen Effects on Asprin Treated Volunteers
Information source: Gebro Pharma GmbH
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug Interactions
Intervention: S(+)-ibuprofen (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Gebro Pharma GmbH Official(s) and/or principal investigator(s):
Christian Joukhadar, MD, Principal Investigator, Affiliation: Department of Clinical Pharmacology, Division of Clinical Pharmacokinetics, Medical Univerisity of Vienna
Summary
The purpose of this clinical trial is to determine whether S(+)-ibuprofen affect the platelet
inhibition under steady state acetylsalicylic acid conditions.
Clinical Details
Official title: Double Blind, Randomised, Parallel Group, Placebo Controlled Clinical Trial of S(+)-Ibuprofen Effects on TxB2 Concentrations and Platelet Aggregation in Aspirin-Treated Healthy Adult Volunteers
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study
Primary outcome: Percentage of inhibition of TxB2 after 1, 3, 7 and 10 days
Secondary outcome: percentage of subjects with >90% inhibition of TxB2, CEPI-CT and CADP-CT measured by PAF100,prostacyclin metabolite
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Department of Clinical Pharmacology, Medical University Vienna, Vienna 1090, Austria
Additional Information
Related publications: Cryer B, Berlin RG, Cooper SA, Hsu C, Wason S. Double-blind, randomized, parallel, placebo-controlled study of ibuprofen effects on thromboxane B2 concentrations in aspirin-treated healthy adult volunteers. Clin Ther. 2005 Feb;27(2):185-91.
Starting date: September 2006
Last updated: March 1, 2007
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