Status:
COMPLETED
Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets
Lead Sponsor:
Blu Caribe
Conditions:
Bioavailability
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether two oral formulations of Gemfibrozil Tablets are bioequivalent.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00800475
Start Date
July 1 2005
End Date
September 1 2005
Last Update
August 13 2013
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