Bioequivalence Study of Fenofibrate 160mg Tablets Under Fed Conditions

NCT00775359 | Completed DMC

• 1 other identifier: AA01824
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

bioequivalence fenofibrate tablets

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

Fenofibrate 160mg Tablets of Ranbaxy

Drug: Fenofibrate 160 mg tablets

2

ACTIVE COMPARATOR

TriCor® 160 mg Fenofibrate Tablets

Drug: Fenofibrate 160 mg tablets

Interventions

Fenofibrate 160 mg tablets DRUG

1; 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

MDS Pharma Services

Phoenix, Arizona, 85044, United States

Location

Related Links

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MeSH Terms

Interventions

Fenofibrate

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: October 20, 2008
• Study Start: August 1, 2002
• Primary Completion: September 1, 2002
• Study Completion: October 1, 2002
• Last Updated: October 20, 2008

Record last verified: 2008-10

Locations

US (1)