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S(+)-Ibuprofen Effects on Asprin Treated Volunteers

This study has been completed.
Sponsor:
Information provided by:
Gebro Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00442585
First received: March 1, 2007
Last updated: March 12, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: March 1, 2007
Last Updated: March 12, 2012
Health Authority: Austria: Agency for Health and Food Safety

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
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013