A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fasting Conditions

Roxane Laboratories1 site in 1 country28 target enrollmentJune 2004

ConditionsSeizures Epilepsy

DrugsOxcarbazepine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Seizures
Sponsor: Roxane Laboratories
Enrollment: 28
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 the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose administered under fasting conditions.

Registry

clinicaltrials.gov

Start Date

June 2004

End Date

July 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 labratory results duirng screening

Exclusion Criteria

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