Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets

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

Completed

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Key information

Conditions

Bioavailability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemfibrozil Tablets

Drug

Primary outcomes

Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity

Sponsors and collaborators

Lead sponsor

Blu Caribe

Industry

Registry information

Official study title

A Relative Bioequivalence Study of 600 mg Gemfibrozil Tablets Under Fasting Conditions

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Dec 2, 2008
Registry last updated: Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed