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S(+)-Ibuprofen Effects on Asprin Treated Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00442585
First Posted: March 2, 2007
Last Update Posted: March 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gebro Pharma GmbH
  Purpose
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442585


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

Publications:
ClinicalTrials.gov Identifier: NCT00442585     History of Changes
Other Study ID Numbers: Gebro-I-24-13
EUDRACT 2006-002159-33
First Submitted: March 1, 2007
First Posted: March 2, 2007
Last Update Posted: March 13, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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