Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00800475

Enrollment

Registered

2008-12-02

Start date

2005-07-31

Completion date

2005-09-30

Last updated

2013-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioavailability

Keywords

bioavailability, Gemfibrozil

Brief summary

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

Interventions

DRUGGemfibrozil Tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026