NCT00951600

Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5 mL Under Fasting Conditions

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 Fasting 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 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 fasting conditions.

Detailed description

Following an overnight fast of at least 10 hours, a single dose of 10 mL of oxcarbazepine 300 mg/5 mL oral suspension (containing oxcarbazepine 300 mg/5rnL) 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 administered a single oral dose of the test or reference formulation of 10 mL of oxcarbazepine 300 mg/5 mL oral suspension (containing oxcarbazepine 300 mg/5mL) according to a randomization schedule. Thirty-five (35) subjects completed both the periods of the study.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2006-09-01
• Primary completion: 2006-10-01
• Completion: 2006-12-01
• First posted: 2009-08-04
• Last updated: 2009-08-04

Locations

1 site across 1 country: India