Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-03-03 @ 4:03 PM
Study NCT ID:
NCT02306902
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2014-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fed Conditions
Sponsor:
Ranbaxy Laboratories Limited
Organization:
Study Overview
Official Title:
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study Comparing Fenofibrate Capsule 130 mg of Ohm Laboratories Inc., USA (A Subsidiary of Ranbaxy Pharmaceuticals Inc., USA) With Antara® Capsule 130 mg (Containing Fenofibrate 130 mg) of Oscient Pharmaceutical Corporation, USA in Healthy, Adult, Male Human Subjects Under Fed Conditions
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Following an overnight fast of at least 10 hour, a high-fat high calorie breakfast was served to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of fenofibrate capsules 130 mg of either test or reference formulation was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and under supervision of trained study personnel.
Blood samples were collected at pre-dose and at 1.000, 2.000, 3.000, 4.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 7.500, 8.000, 8.500, 9.000, 9.500, 10.000, 11.000, 12.000, 16.000, 24.000, 36.000, 48.000, 72.000 and 96.000 hours post dose in each period under low light condition. 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. Post-dose samples were generally collected within 2 minutes of the scheduled time.
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.
Following an overnight fast of at least 10 hour, a high-fat high calorie breakfast was served to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of fenofibrate capsules 130 mg of either test or reference formulation was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and under supervision of trained study personnel.
Blood samples were collected at pre-dose and at 1.000, 2.000, 3.000, 4.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 7.500, 8.000, 8.500, 9.000, 9.500, 10.000, 11.000, 12.000, 16.000, 24.000, 36.000, 48.000, 72.000 and 96.000 hours post dose in each period under low light condition. 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. Post-dose samples were generally collected within 2 minutes of the scheduled time.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: