Levetiracetam 750 mg Tablets Under Fasting Conditions
- Registration Number
- NCT00849862
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
The objective of this study is to compare the rate and extent of absorption of a test formulation of Levetiracetam and the reference Keppra® administered as a 1 x 750 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
- 22
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Levetiracetam Levetiracetam Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period Keppra® Keppra® Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
- Primary Outcome Measures
Name Time Method Cmax - Maximum Observed Concentration Blood samples collected over 36 hour period Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) Blood samples collected over 36 hour period Bioequivalence based on AUC0-inf
AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) Blood samples collected over 36 hour period Bioequivalence based on AUC0-t
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SFBC-Anapharm
🇨🇦Sainte-Foy, Quebec, Canada