Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fasting 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/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.