Bioequivalency Study of Fenofibrate 160mg Tablets Under Fasting Conditions

NCT00775827 | Completed DMC

• 1 other identifier: 028/FENOF-160/02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

bioequivalence fenofibrate tablets

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

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

Interventions

fenofibrate 160 mg tablets DRUG

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Ranbaxy Research Laboratories

Gurgaon, Haryana, India

Location

Related Links

• Related Info
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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: November 1, 2002
• Primary Completion: December 1, 2002
• Study Completion: December 1, 2002
• Last Updated: October 20, 2008

Record last verified: 2008-10

Locations

IN (1)