Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fed 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, single-dose, crossover, bioequivalence study comparing Fenofibrate capsules, USP 130 mg manufactured by Ohm Laboratories Inc, NJ 08901 with ANTARA® (fenofibrate) capsules 130 mg manufactured by Ethypharm Industries Saint Cloud, France for Oscient Pharmaceuticals Corp. Waltham, MA 02451 in healthy, adult, male, human subjects under fed 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 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.

• Had a non-vegetarian dietary habit.

Exclusion Criteria:

• Subject had history of hypersensitivity to fenofibrate or any related drug or to any other drug.

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

• Subjects with history of unexplained persistent liver function abnormality.

• Subjects with history of preexisting gallbladder disease.

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

• Subject had any evidence of organ dysfunction or any clinically significant deviation from the normal in physical or clinical determinations.

• Clinically abnormal ECG or Chest X-ray, or hematological and biochemical parameters which was/were outside acceptable limits and was judged clinically significant by investigator.

• Investigations with blood samples of the subject showed presence of disease markers of HIV 1 or 2, Hepatitis B or C Viruses of syphilis infection.

• Investigations with urine samples of the subject showed clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4 /HPF), glucose (Positive) or Protein (Positive).

• Subject had history of serious medical illnesses including but not limited to gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological 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 10 or more cigarettes daily or had 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.

• Use of any regular medication (OTC or prescription) or any drug metabolizing enzyme within 30 days prior to Day 1 of this study.

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participated in a clinical trial within 12 weeks preceding admission of this study (except for the subjects who dropout/withdrawn from the previous study prior to period I 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

• Consumption of grapefruit juice and or grape fruit supplements containing products for 48 hours prior to admission.

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