A Single Site, Open-label, Randomized, Single-dose, Two-way Cross-over Study in Healthy Japanese Subjects to Evaluate the Bioequivalence, Safety & Tolerability of Levetiracetam Administered as an Oral Tablet or Intravenous Infusion

UCB Pharma0 sites25 target enrollmentJune 2011

ConditionsHealthy Volunteers

InterventionsLevetiracetam

DrugsLevetiracetam

Overview

Phase: Phase 1
Intervention: Levetiracetam
Conditions: Healthy Volunteers
Sponsor: UCB Pharma
Enrollment: 25
Primary Endpoint: Maximum drug concentration (Cmax)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

September 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

UCB Pharma

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Levetiracetam IV Infusion (1500 mg)

Intervention: Levetiracetam

Levetiracetam tablets (1500 mg)

Intervention: Levetiracetam

Outcomes

Primary Outcomes

Maximum drug concentration (Cmax)

Time Frame: 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)

Time Frame: 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 Outcomes

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)