NCT01132352

Bioequivalence Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fed Conditions

Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Levetiracetam Tablets, 750 mg and Keppra® 750 mg Tablets of UCB Pharma in Healthy Adult Male Volunteers Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the single-dose relative bioavailability study of Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under fed conditions.

Detailed description

This is an open-label, randomized, single-dose 2-way crossover relative bioavailability study in healthy adult male volunteers under fed conditions with a washout period of 7 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Levetiracetam	Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited

Timeline

• Start date: 2003-09-01
• Primary completion: 2003-10-01
• Completion: 2003-11-01
• First posted: 2010-05-28
• Last updated: 2010-06-14

Locations

1 site across 1 country: United States