Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fasting Conditions

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover bioequivalence study comparing a single oral dose of fenofibrate capsules, USP 130 mg, of Ohm Laboratories Inc. USA (a subsidiary of Ranbaxy Pharmaceutical Inc.) with Antara® (fenofibrate) Capsules 130 mg of Oscient Pharmaceuticals Corporation USA, in healthy, adult, male, human subjects under fasting condition.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ranbaxy Laboratories Limited
• Treatments: Fenofibrate

Criteria

Inclusion Criteria:

Volunteers who met the following criteria were included in the study

• Were in the age range of 18-45 years.

• Were neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases

• Had voluntarily given written informed consent to participate in this study.

• Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.

Exclusion Criteria:

• History of hypersensitivity to fenofibrate or any other related drug.

• Subjects with history of hepatic or severe renal dysfunction, including primary biliary cirrhosis.

• Subjects with history of unexplained persistent liver function abnormality.

• Subject had history of myalgia, muscle tenderness or weakness or myopathy.

• History of abdominal pain in one week preceding the study.

• History of recurrent headache and/or back pain.

• History of constipation and/or nausea in one week preceding the study.

• History and/or any finding of gall bladder disease.

• History of pancreatitis.

• History of drug-induced rash and/or pruritis. - Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.

• Subject had laboratory test parameter(s), which is/are outside acceptable limits and is judged clinically significant.

• Subject had history of serious medical illnesses including but not limited to gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes, glaucoma, any serious, potentially life-threatening illness.

• Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that might impair the ability to provide, written informed consent.

• Subject was a regular smoker, who smoked more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.

• Subject had history of drug dependence or excessive alcohol intake on a habitual basis or has difficulty in abstaining for the duration of each study period or has consumed alcohol 48 hours prior to admission.

• Subject had used an enzyme modifying drugs within 30 days prior to admission of this study.

• Subject had participated in a clinical trial within 12 weeks preceding admission of this study (except for subjects who dropout / are withdrawn from the previous study prior to period 1 dosing)

• Subject had donated and/or lost more than 350 mL of blood in the past 3 months, including blood loss in this study.

• Consumption of alcohol for 48 hours prior to admission.

• Subject had problem(s) in complying with the study protocol.