NCT00850174

Oxcarbazepine 600 mg Tablets Under Fasting Conditions

A Single-Dose, Comparative Bioavailability Study of Two Formulations of Oxcarbazepine 600 mg Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the comparative bioavailability between Oxcarbazepine 600 mg Tablets (test) and Trileptal® 600 mg Tablets (reference) after a single-dose in healthy subjects under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oxcarbazepine	600 mg Tablet
DRUG	Trileptal®	600 mg Tablet

Timeline

• Start date: 2005-04-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2009-02-24
• Last updated: 2024-08-19
• Results posted: 2009-08-18

Locations

1 site across 1 country: Canada