A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Human Volunteers
Interventions
DRUG

Levetiracetam

Levetiracetam 1.500 mg (500 mg/ 5 mL vials) administered as a 45 minutes intravenous infusion diluted in 100 mL 0.9 % saline solution every 12 hours from the morning of Day 3 (it is the first day in Part B) to the morning of Day 7 (it is the 5th day in Part B).

OTHER

Placebo

15 mL 0.9 % saline solution added to 100 mL 0.9 % saline solution, administered as a 45 minutes intravenous infusion every 12 hours from the morning of Day 3 ( it is the 1st day in Part B) to the morning of Day 7 (it is the 5th day in Part B).

Trial Locations (1)

Unknown

1, Shanghai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

UCB Pharma

INDUSTRY