NCT00775359

Bioequivalence Study of Fenofibrate 160mg Tablets Under Fed Conditions

Comparative, Randomized, Single-Dose, 2-Way Crossover Relative Bioavailability Study of Ranbaxy and Abbott (TriCor®) 160 mg Fenofibrate Tablets in Healthy Adult Volunteers Under Fed Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Abbott (TriCor) 160 mg fenofibrate tablets under fed conditions.

Detailed description

This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male and female volunteers A total of 23 subjects (16 males and 7 females) completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 24-hour blood draw. Subjects returned for all subsequent blood draws. Doses were separated by a washout period of 10 days. Of the 24 healthy adult male and female volunteers enrolled in the study, 23 subjects (16 males and 7 females) completed the clinical phase of the study. Subject No. 10 failed to return for Period 2 check-in.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fenofibrate 160 mg tablets

Timeline

• Start date: 2002-08-01
• Primary completion: 2002-09-01
• Completion: 2002-10-01
• First posted: 2008-10-20
• Last updated: 2008-10-20

Locations

1 site across 1 country: United States