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Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets

NCT ID: NCT00800475

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-09-30

Brief Summary

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

Detailed Description

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Conditions

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Bioavailability

Keywords

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bioavailability Gemfibrozil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test Drug

Group Type ACTIVE_COMPARATOR

Gemfibrozil Tablets

Intervention Type DRUG

Reference Drug

Group Type ACTIVE_COMPARATOR

Gemfibrozil Tablets

Intervention Type DRUG

Interventions

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Gemfibrozil Tablets

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Blu Caribe

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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R05-0116

Identifier Type: -

Identifier Source: org_study_id