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S(+)-Ibuprofen Effects on Asprin Treated Volunteers

This study has been completed.
Information provided by:
Gebro Pharma GmbH Identifier:
First received: March 1, 2007
Last updated: March 12, 2012
Last verified: March 2012
The purpose of this clinical trial is to determine whether S(+)-ibuprofen affect the platelet inhibition under steady state acetylsalicylic acid conditions.

Condition Intervention Phase
Drug Interactions Drug: S(+)-ibuprofen Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Gebro Pharma GmbH:

Primary Outcome Measures:
  • Percentage of inhibition of TxB2 after 1, 3, 7 and 10 days

Secondary Outcome Measures:
  • percentage of subjects with >90% inhibition of TxB2, CEPI-CT and CADP-CT measured by PAF100,
  • prostacyclin metabolite

Estimated Enrollment: 72
Study Start Date: September 2006
Study Completion Date: October 2007

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00442585

Department of Clinical Pharmacology, Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Gebro Pharma GmbH
Principal Investigator: Christian Joukhadar, MD Department of Clinical Pharmacology, Division of Clinical Pharmacokinetics, Medical Univerisity of Vienna
  More Information

Publications: Identifier: NCT00442585     History of Changes
Other Study ID Numbers: Gebro-I-24-13
EUDRACT 2006-002159-33
Study First Received: March 1, 2007
Last Updated: March 12, 2012

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 21, 2017