Levetiracetam 1000 mg Under Non-Fasting Conditions
- Registration Number
- NCT00859430
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
The objective of this study is to compare the rate and extent of absorption of an investigational formulation of levetiracetam 1000 mg tablet to an equivalent oral dose of the commercially available reference product under fed 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 Keppra® Keppra® Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period Levetiracetam Levetiracetam Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) 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 the 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)
CEDRA Clinical Research, LLC
🇺🇸San Antonio, Texas, United States