NCT00849797

Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions

Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Oxcarbazepine 600 mg Tablet and Trileptal® Following a 600 mg Dose in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the rate and extent of absorption of a test formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose under fed 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: 2005-07-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2009-02-24
• Last updated: 2024-08-19
• Results posted: 2009-08-18

Locations

1 site across 1 country: Canada