NCT02306889

Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fasting Conditions

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fenofibrate	130mg Capsules
DRUG	ANTARA® (fenofibrate)	130mg Capsules

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-01-01
• Completion: 2010-04-01
• First posted: 2014-12-03
• Last updated: 2014-12-03