A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Roxane Laboratories1 site in 1 country48 target enrollmentNovember 2004

ConditionsSeizures Epilepsy

DrugsOxcarbazepine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Seizures
Sponsor: Roxane Laboratories
Enrollment: 48
Locations: 1
Primary Endpoint: Bioequivalence
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study was to assess bioequivalence of a potential generic 600 mb oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose, administered with food.

Registry

clinicaltrials.gov

Start Date

November 2004

End Date

November 2004

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Roxane Laboratories

Eligibility Criteria

Inclusion Criteria

•No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results at screening.

Exclusion Criteria

•Positive test for HIV, Hepatitis B, or Hepatitis C.
•Treatment with any known enzyme altering drugs.
•History of allergic or adverse response to oxcarbazepine or any other comparable or similar product.