Bioequivalence Study of Fenofibrate 160mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00775359
First received: October 17, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Healthy
Drug: Fenofibrate 160 mg tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2002
Study Completion Date: October 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fenofibrate 160mg Tablets of Ranbaxy
Drug: Fenofibrate 160 mg tablets
Active Comparator: 2
TriCor® 160 mg Fenofibrate Tablets
Drug: Fenofibrate 160 mg tablets

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subject candidates must fulfill the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:

  • Healthy adult male and female volunteers, 18-55 years of age;
  • Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
  • Medically healthy subjects with no clinically abnormal laboratories and ECGs, as deemed by the principal investigator;
  • Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:

    • Surgically sterile (tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum. Proof is required for the hysterectomy and oophorectomy;
    • IUD in place for at least 3 months;
    • Barrier methods with spermicide (condom, diaphragm) for at least 14 days prior to the start of the study and throughout the study;
    • Surgical sterilization of the partner (vasectomy for 6 months minimum);
    • Hormonal contraceptives for at least 3 months prior to the start of the study. Other birth control methods may be deemed acceptable.
  • Postmenopausal women with amenorrhea for at least 2 years;
  • Voluntary consent to participate in the study.

Exclusion Criteria:

Subject candidates must not be enrolled in the study if they meet any of the following criteria:

  • History or presence of significant: cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
  • In addition, history or presence of:

    • alcoholism or drug abuse within the past 2 years;
    • hypersensitivity or idiosyncratic reaction to fenofibrate or other lipid regulating agents.
  • Female subjects who are pregnant or lactating.
  • Subjects who have been on an abnormal diet (for whatever reason) during the 30 days prior to the first dosing.
  • Subjects who have made a donation (standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 30 days prior to the study.
  • Subjects who have made a plasma donation within 7 days prior to the study.
  • Subjects who have participated in another clinical trial within 30 days prior to the first dose.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775359

Locations
United States, Arizona
MDS Pharma Services
Phoenix, Arizona, United States, 85044
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories
ClinicalTrials.gov Identifier: NCT00775359     History of Changes
Other Study ID Numbers: AA01824
Study First Received: October 17, 2008
Last Updated: October 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:
bioequivalence fenofibrate tablets

Additional relevant MeSH terms:
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014