Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets

Blu Caribe

Status and phase: Completed; Phase 1

Conditions: Bioavailability

Treatments: Drug: Gemfibrozil Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00800475

R05-0116

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Test Drug

Active Comparator group

Treatment:

Drug: Gemfibrozil Tablets

Reference Drug

Active Comparator group

Treatment:

Drug: Gemfibrozil Tablets