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Bioequivalency Study of Fenofibrate 160mg Tablets Under Fasting Conditions

2014-08-27 03:26:50 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy

Intervention

fenofibrate 160 mg tablets

Location

Ranbaxy Research Laboratories
Gurgaon
Haryana
India

Status

Completed

Source

Ranbaxy Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:26:50-0400

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Medical and Biotech [MESH] Definitions

Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)

An antilipemic agent which reduces both CHOLESTEROL and TRIGLYCERIDES in the blood.

Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.

Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.

A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.

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