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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00775827 |
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.
Condition | Intervention |
---|---|
Healthy |
Drug: fenofibrate 160 mg tablets |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | 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 |
Enrollment: | 40 |
Study Start Date: | November 2002 |
Study Completion Date: | December 2002 |
Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
fenofibrate 160 mg tablets of Ranbaxy Laboratories
|
Drug: fenofibrate 160 mg tablets |
2: Active Comparator
Tricor 160 mg tablets
|
Drug: fenofibrate 160 mg tablets |
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Be of normal health as determined by medical history and physical examination of the subjects performed within 28 days prior to the commencement of the study.
If female and:
Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or TS postmenopausal for at least 1 year; or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Exclusion Criteria:
History of allergy to fenofibrate and related fibric acid derivatives.
Female volunteers demonstrating a positive pregnancy screen.
Female volunteers who are currently breasffeeding.
Clinically abnormal chemical and microscopic examination of urine defined as presence .of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose (positive) and protein (positive).
Clinically abnormal ECG and Chest X-ray.
Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
Participation in any clinical trial within 6 weeks preceding Day ! of this study.
Responsible Party: | Ranbaxy Research Laboratories ( Dr. Tausif Monif ) |
Study ID Numbers: | 028/FENOF-160/02 |
Study First Received: | October 17, 2008 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00775827 |
Health Authority: | India: Drugs Controller General of India |
bioequivalence fenofibrate tablets |
Healthy Procetofen |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Pharmacologic Actions |