Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fed Conditions

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.