Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions
Not Applicable
Completed
- Conditions
- SeizuresEpilepsy
- Registration Number
- NCT00616681
- 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 compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose administered under fasting conditions.
- 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 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.
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