Bioequivalency Study of Fenofibrate 160mg Tablets Under Fasting Conditions

October 17, 2008 updated by: Ranbaxy Laboratories Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Gurgaon, Haryana, India
        • Ranbaxy Research Laboratories

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Be in the age range of 18-45 years.
  • Be neither overweight nor underweight for his/her height as per te Life insurance Corporation of india height/weight chart for non-medical cases.
  • Have voluntarily given written informed consent to participate in this study.

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.

  • History of gall stones/cholecystitis
  • Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  • Presence of disease markers of H~-I and 2, Hepatitis B and C viruses and syphilis infection.

Female volunteers demonstrating a positive pregnancy screen.

Female volunteers who are currently breasffeeding.

  • Presence of values which are clinically significantly different from normal reference ranges (as defined in Appendix 5) for haemoglobin, total white blood cells count, differential WBC count and platelet count.
  • Positive for urinary screen testing of drugs of abuse (opiates and cannabinoids)
  • Presence of values which are significantly different from normal reference ranges (as defined in Appendix 5) for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose, serum cholesterol and serum triglycerides.

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.

  • History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.
  • History of any psychiatric illness which may impair the ability to provide written informed consent.
  • Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
  • History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (! Unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the'duration of each study period.

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.

  • Subjects who, through completion of this study, would have donated and/or lost more than 35;0 mL of blood in the past 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
fenofibrate 160 mg tablets of Ranbaxy Laboratories
Drug: fenofibrate 160 mg tablets
Active Comparator: 2
Tricor 160 mg tablets
Drug: fenofibrate 160 mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bioequivalence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ranbaxy Laboratories Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (Estimate)

October 20, 2008

Study Record Updates

Last Update Posted (Estimate)

October 20, 2008

Last Update Submitted That Met QC Criteria

October 17, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 028/FENOF-160/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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