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Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00800475
First Posted: December 2, 2008
Last Update Posted: August 13, 2013
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 (Responsible Party):
Blu Caribe
  Purpose
The purpose of this study is to determine whether two oral formulations of Gemfibrozil Tablets are bioequivalent.

Condition Intervention Phase
Bioavailability Drug: Gemfibrozil Tablets Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Relative Bioequivalence Study of 600 mg Gemfibrozil Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Blu Caribe:

Primary Outcome Measures:
  • Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity

Enrollment: 40
Study Start Date: July 2005
Study Completion Date: September 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Test Drug Drug: Gemfibrozil Tablets
Active Comparator: Reference Drug Drug: Gemfibrozil Tablets

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy men or women 18 years of age or older
  • weight within +/- 20% for height and body frame
  • willing to participate and sign a copy of the informed consent form

Exclusion Criteria:

  • recent history of drug or alcohol addiction or abuse
  • pregnant or lactating women
  • history of allergic response to gemfibrozil
  • use of tobacco products
  • evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
  • receipt of any drugs as part of a research study within 28 days prior to study dosing
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Blu Caribe
ClinicalTrials.gov Identifier: NCT00800475     History of Changes
Other Study ID Numbers: R05-0116
First Submitted: November 26, 2008
First Posted: December 2, 2008
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by Blu Caribe:
bioavailability
Gemfibrozil

Additional relevant MeSH terms:
Gemfibrozil
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors