Trials / Completed

CompletedNCT00926302

A Bioequivalence Study of Levetiracetam Versus Keppra

A Randomized, Single, Two-Way Crossover Pivotal Study to Assess the Bioequivalence Study of Levetiracetam vs. Keppra Administered Under Fasting Conditions to Healthy Adult Subject

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 26 (actual)

Sponsor: Tri-Service General Hospital · Academic / Other
Sex: Male
Age: 20 Years – 40 Years
Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra administered under fasting conditions to healthy adult subjects.

Detailed description

This study is a randomized, single, two-way crossover pivotal study. The pharmacokinetic blood samples and vital signs were obtained before and after administration at scheduled intervals as indicated in the study protocol.

Conditions

Healthy

Interventions

Type	Name	Description
DRUG	Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)	Levetiracetam 500mg/tablet Oral once
DRUG	Keppra (Levetiracetam - USB SA Pharma Sector)	Levetiracetam 500mg/tablet oral once

Timeline

Start date: 2008-01-01
Primary completion: 2009-02-01
Completion: 2009-04-01
First posted: 2009-06-23
Last updated: 2009-06-23

Source: ClinicalTrials.gov record NCT00926302. Inclusion in this directory is not an endorsement.