Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Blu Caribe
ClinicalTrials.gov Identifier:
NCT00800475
First received: November 26, 2008
Last updated: August 9, 2013
Last verified: August 2013
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Blu Caribe
ClinicalTrials.gov Identifier: NCT00800475     History of Changes
Other Study ID Numbers: R05-0116
Study First Received: November 26, 2008
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Blu Caribe:
bioavailability
Gemfibrozil

Additional relevant MeSH terms:
Gemfibrozil
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014