Levetiracetam 750 mg Tablets Under Non-Fasting Conditions
- Registration Number
- NCT00849485
- 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 tablets versus the reference Keppra® administered as a 1 x 750 mg tablet 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® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period Levetiracetam Levetiracetam Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of Levetiracetam's action on GABA and glutamate systems in epilepsy treatment?
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What adverse events are commonly associated with Levetiracetam 750 mg dosage in clinical trials?
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Trial Locations
- Locations (1)
SFBC Anapharm
🇨🇦Sainte-Foy, Quebec, Canada