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

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

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.

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.