An Open Label, Balanced, Randomized, Two-treatment, Two -Period, Two -Sequence, Crossover Bioequivalence Study Comparing a Single Oral Dose of Fenofibrate 130 mg Capsules of Ohm Laboratories Inc. USA (a Subsidiary of Ranbaxy Pharmaceutical Inc.) With Antara® 130 mg Capsules (Containing Fenofibrate 130 mg) of Oscient Pharmaceuticals Corporation USA, in Healthy, Adult, Male, Human Subjects Under Fasting Condition.

Brief Summary

Detailed Description

The subjects were subjected to breath test for alcohol and test for drugs of abuse (opioids and cannabinoids) in urine prior to admission in each period. All subjects fasted overnight for at least 10 hours before the morning dose and for 4 hours post-dose during each period of the study. A single oral dose of either test (T) or reference (R) was administered with 240 mL of drinking water at ambient temperature under supervision of trained study personnel. Both test and reference products were administered to all the study subjects, one in each period (except subject numbers 17, 27 and 42). Blood samples were collected at Predose (duplicate) and at 1.000, 2.000, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 7.500, 8.000, 8.500, 9.000, 10.000, 11.000, 12.000, 16.000, 24.000, 36.000, 48.000, 72.000 and 96.000 hours post dose, in pre-chilled vacutainers, under low light condition, in each period from all completed subjects. The pre-dose blood samples in each period were collected in duplicate (2 x 5 mL), within a period of 1.5 hour before dosing. The actual end time of collection of each blood sample was recorded. During the course of the study, safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis at screening). Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry were repeated at the end of the study.

Primary Outcomes