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Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets

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ClinicalTrials.gov Identifier: NCT00800475
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):
Blu Caribe

Brief Summary:
The purpose of this study is to determine whether two oral formulations of Gemfibrozil Tablets are bioequivalent.

Condition or disease Intervention/treatment Phase
Bioavailability Drug: Gemfibrozil Tablets Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : July 2005
Primary Completion Date : July 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Gemfibrozil
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Test Drug Drug: Gemfibrozil Tablets
Active Comparator: Reference Drug Drug: Gemfibrozil Tablets



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


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

Responsible Party: Blu Caribe
ClinicalTrials.gov Identifier: NCT00800475     History of Changes
Other Study ID Numbers: R05-0116
First Posted: December 2, 2008    Key Record Dates
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