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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014