Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Not Applicable

Completed

• Conditions: Seizures; Epilepsy

• Registration Number: NCT00618046
• Lead Sponsor: Roxane Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-15
• Study First Posted: 2008-02-18
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bioequivalence	Baseline, Two Period, Seven day washout

Trial Locations

Locations (1)

Bio-Kinetics Clinical Applications, Inc .; 🇺🇸 Springfield, Missouri, United States