NCT00775827

Bioequivalency Study of Fenofibrate 160mg Tablets Under Fasting Conditions

A Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Fenofibrate Formulations Comparing Fenofibrate 160 mg Tablets of Ranbaxy Laboratories With Tricor 160 mg Tablets of in Healthy, Adult, Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose crossover bioavailability study on fenofibrate formulations comparing fenofibrate 160 mg tablets of Ranbaxy Laboratories with Tricor 160 mg tablets in healthy, adult, human subjects under fasting conditions.

Detailed description

This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 40 healthy adult male subjects. As per protocol, enough healthy, adult, human subjects were to be enrolled in the study to allow the dosing of 40 subjects in the first period. 40 subjects were enrolled and a total of 37 subjects completed both the periods of study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	fenofibrate 160 mg tablets

Timeline

• Start date: 2002-11-01
• Primary completion: 2002-12-01
• Completion: 2002-12-01
• First posted: 2008-10-20
• Last updated: 2008-10-20

Locations

1 site across 1 country: India