Bioequivalence Study of Fenofibrate 160mg Tablets Under Fed Conditions
NCT ID: NCT00775359
Last Updated: 2008-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2002-08-31
2002-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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1
Fenofibrate 160mg Tablets of Ranbaxy
Fenofibrate 160 mg tablets
2
TriCor® 160 mg Fenofibrate Tablets
Fenofibrate 160 mg tablets
Interventions
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Fenofibrate 160 mg tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Ranbaxy Laboratories Limited
INDUSTRY
Responsible Party
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Ranbaxy Research Laboratories
Locations
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MDS Pharma Services
Phoenix, Arizona, United States
Countries
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Related Links
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Related Info
Related Info
Related Info
Other Identifiers
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AA01824
Identifier Type: -
Identifier Source: org_study_id