Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets

Bioavailability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800475
• Other study ID #: R05-0116
• Status: Completed
• Phase: Phase 1
• First received: November 26, 2008
• Last updated: August 9, 2013
• Start date: July 2005
• Est. completion date: September 2005

Study information

• Verified date: August 2013
• Source: Blu Caribe
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bioavailability

Intervention

Drug:
• Gemfibrozil Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Blu Caribe

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity			No