Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects
- Registration Number
- NCT01394224
- Lead Sponsor
- UCB Pharma
- Brief Summary
The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg and a single oral dose(tablets) of 1500 mg in healthy Japanese subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Healthy Japanese male and female volunteers with the age between 20 and 55 years old
Exclusion Criteria
- Subject has participated or is participating in any other clinical studies of investigational drug or another IMP within the last 3 months
- Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
- Subject is pregnant or lactating female.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Levetiracetam tablets (1500 mg) Levetiracetam - Levetiracetam IV Infusion (1500 mg) Levetiracetam -
- Primary Outcome Measures
Name Time Method Maximum drug concentration (Cmax) Multiple sampling from 0 to 36 hours following single dose Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUCo-t) Multiple sampling from 0 to 36 hours (could be less than 36 hours if the last quantifiable concentration is below limit of quantification), following single dose
- Secondary Outcome Measures
Name Time Method Time to reach maximum plasma concentration (tmax) Multiple sampling from 0 to 36 hours following single dose Plasma concentration at the end of infusion (C15' ) At 15 minutes after termination of the15-minutes infusion Area under the curve from 0 to infinity (AUC) Multiple sampling from 0 to 36 hours following single dose Mean resident time (MRT) Multiple sampling from 0 to 36 hours following single dose Terminal elimination half-life(t1/2) Multiple sampling from 0 to 36 hours following single dose First order terminal elimination rate constant (λz ) Multiple sampling from 0 to 36 hours following single dose Total body clearance after oral administration (CL/F) or after IV infusion (CL) Multiple sampling from 0 to 36 hours following single dose Volume of distribution after oral administration(Vz/F) or after IV infusion(Vz) Multiple sampling from 0 to 36 hours following single dose