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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00849485 |
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.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Levetiracetam Drug: Keppra® |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Levetiracetam 750 mg Tablet and Keppra® (Reference) Following a 750 mg Dose in Healthy Subjects Under Fed Conditions |
Enrollment: | 22 |
Study Start Date: | November 2005 |
Study Completion Date: | November 2005 |
Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Levetiracetam: Experimental
Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period
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Drug: Levetiracetam
750 mg Tablet
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Keppra®: Active Comparator
Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
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Drug: Keppra®
750 mg Tablet
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Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
Subjects to whom any of the following applies will be excluded from the study:
Study ID Numbers: | 50277 |
Study First Received: | February 20, 2009 |
Results First Received: | June 30, 2009 |
Last Updated: | June 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00849485 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Bioequivalence Healthy Subjects |
Nootropic Agents Malnutrition Piracetam Etiracetam |
Healthy Neuroprotective Agents Anticonvulsants |
Nootropic Agents Therapeutic Uses Physiological Effects of Drugs Piracetam Etiracetam |
Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |