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

UCB Pharma25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

LevetiracetamDRUG

Strength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose

LevetiracetamDRUG

Levetiracetam tablets Strength: 500 mg Form: Tablet Frequency: Single dose

Eligibility

Sex: ALLMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

London, United Kingdom