Bioavailability Study Between Two Oral Formulations of Gemfibrozil Tablets

This study has been completed.

First Received: November 26, 2008 Last Updated: December 1, 2008 History of Changes

Sponsored by:	Perrigo Company
Information provided by:	Perrigo Company
ClinicalTrials.gov Identifier:	NCT00800475

Purpose

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

Condition	Intervention
Bioavailability	Drug: Gemfibrozil Tablets

Drug Information available for: Gemfibrozil

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Relative Bioavailability Study of 600 mg Gemfibrozil Tablets Under Fasting Conditions

Further study details as provided by Perrigo Company:

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
Test Drug: Active Comparator	Drug: Gemfibrozil Tablets
Reference Drug: Active Comparator	Drug: Gemfibrozil Tablets

Eligibility

Criteria

Inclusion Criteria:

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:	Perrigo Company ( Diane Morgan )
Study ID Numbers:	R05-0116
Study First Received:	November 26, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00800475 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Perrigo Company:

bioavailability
Gemfibrozil

Study placed in the following topic categories:

Antimetabolites
Gemfibrozil
Antilipemic Agents

Additional relevant MeSH terms:

Antimetabolites
Gemfibrozil
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Antilipemic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009