Bioequivalence Study of 200 mg Lamotrigine Tablet Under Fasting Conditions
- Registration Number
- NCT00834561
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
This is a bioequivalence study to compare the rate and extent of absorption of lamotrigine (test) and Lamictal® (reference)administered as a 1 x 200 mg tablet under fasting conditions.
- Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lamictal® Lamictal® Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period Lamotrigine Lamotrigine Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
- Primary Outcome Measures
Name Time Method Cmax - Maximum Observed Concentration Blood samples collected over 120 hour period Bioequivalence based on Cmax
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) Blood samples collected over 120 hour period Bioequivalence based on AUC0-t
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) Blood samples collected over 120 hour period Bioequivalence based on AUC0-inf
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Anapharm Inc.
🇨🇦Sainte-Foy, Quebec, Canada