NCT00859521

Levetiracetam 1000 mg Under Fasting Conditions

A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Levetiracetam 1000 mg Tablet Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Levetiracetam	1000 mg Tablet
DRUG	Keppra®	1000 mg Tablet

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2009-03-11
• Last updated: 2024-08-20
• Results posted: 2009-08-25

Locations

1 site across 1 country: United States