Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
Not Applicable
Completed
- Conditions
- SeizuresEpilepsy
- Registration Number
- NCT00616863
- Lead Sponsor
- Roxane Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Bioequivalence Baseline, two period, 7 day washout
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MDS Pharma Services
🇨🇦Montreal, Quebec, Canada