Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Blu Caribe
• Treatments: Gemfibrozil

Criteria

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