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S(+)-Ibuprofen Effects on Asprin Treated Volunteers

Information source: Gebro Pharma GmbH
ClinicalTrials.gov processed this data on August 23, 2015
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


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: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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 12, 2012

Page last updated: August 23, 2015

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