Trials / Completed
CompletedNCT00849862
Levetiracetam 750 mg Tablets Under Fasting Conditions
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 Fasting Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Teva Pharmaceuticals USA · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levetiracetam | 750 mg Tablet |
| DRUG | Keppra® | 750 mg Tablet |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2005-11-01
- Completion
- 2005-11-01
- First posted
- 2009-02-24
- Last updated
- 2009-09-11
- Results posted
- 2009-08-04
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00849862. Inclusion in this directory is not an endorsement.