NCT00616863
Completed
Not Applicable
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazapine 600 mg Tablets Under Fed Conditions
DrugsOxcarbazepine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epilepsy
- Sponsor
- Roxane Laboratories
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Bioequivalence
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The objective of this study was to assess the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, folloiwng a single 600 mg dose administered with food.
Investigators
Eligibility Criteria
Inclusion Criteria
- •No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results during screening.
Exclusion Criteria
- •Positive test for HIV, Hepatitis B, or Hepatitis C.
- •Treatment with known enzyme altering drugs.
- •History of allergic or advers response to oxcarbazepine or any other comparable or similar product.
Outcomes
Primary Outcomes
Bioequivalence
Time Frame: Baseline, two period, 7 day washout
Study Sites (1)
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