NCT00951847

Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5mL Under Fed Condition

An Open Label, Balanced, Randomised, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover Bioavailability Study Comparing Oxcarbazepine 300 mg/5mL Oral Suspension of OHM Laboratories (a Subsidiary of Ranbaxy Pharmaceuticals Inc.) With Trileptal® 300 mg/5mL Oral Suspension (Containing Oxcarbazepine 300 mg/5mL) of Novartis Pharmaceutical Corporation in Healthy, Adult, Male, Human Subjects Under Fed Condition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the single-dose oral bioavailability of oxcarbazepine 300 mg/5mL oral suspension of OHM Laboratories, USA (a subsidiary of Ranbaxy Pharmaceuticals Inc.) with Trileptal® 300 mg/5mL oral suspension (containing oxcarbazepine 300 mg/5mL) of Novartis Pharmaceutical Corporation, USA in healthy, adult, male, human subjects under fed conditions.

Detailed description

The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing oxcarbazepine 300 mg/5mL oral suspension of OHM Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc.) with Trileptal® 300 mg/5mL oral suspension (containing oxcarbazepine 300 mg/5mL) of Novartis Pharmaceutical Corporation in healthy, adult, male, human subjects under fed condition. Following an overnight fast of at least 10 hours, all subjects were served a high-fat high calorie breakfast. Thirty minutes after the start of the meal, a single oral dose of 10 mL of oxcarbazepine 300 mg/5 mL oral suspension was administered using a 10 mL graduated syringe, during each period of the study under the supervision of trained study personnel, along with 240 mL of drinking water at ambient temperature. 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 baseline. Laboratory parameters of hematology and biochemistry were repeated at the end of the study. A total of forty (40) subjects were enrolled into the study, to be administered a single oral dose of the test or reference formulation of 10 mL of oxcarbazepine 300 mg/5 mL oral suspension according to a randomization schedule. Thirty-three (33) subjects completed both the periods of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	oxcarbazepine 300 mg/5 mL oral suspension

Timeline

• Start date: 2006-10-01
• Primary completion: 2006-11-01
• Completion: 2006-12-01
• First posted: 2009-08-04
• Last updated: 2009-08-04

Locations

1 site across 1 country: India