NCT01725009

Multiple-dose Study of Levetiracetam Injection in Japanese and Caucasian Healthy Males

A Single-center, Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Levetiracetam Administered as Intravenous Infusion in Japanese and Caucasian Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: UCB Japan Co. Ltd. · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To compare the pharmacokinetics of levetiracetam following single and multiple 15-minute intravenous infusions of 1500 mg levetiracetam between Japanese and Caucasian healthy male subjects

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Multiple 15-minute intravenous infusions of 1500 mg levetiracetam	Strength, 100 mg/mL; Form, concentrate for solution for infusion; Frequency, twice a day; Duration, 7 days

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-11-12
• Last updated: 2013-03-29

Locations

1 site across 1 country: Japan