Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects

UCB

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Levetiracetam

Study type

Interventional

Funder types

Industry

Identifiers

NCT01394224

N01377

2011-000827-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.