---
title: Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects
nct_id: NCT01394224
overall_status: COMPLETED
phase: PHASE1
sponsor: UCB Pharma
study_type: INTERVENTIONAL
primary_condition: Healthy Volunteers
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01394224.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01394224"
ct_last_update_post_date: 2011-10-06
last_seen_at: "2026-05-12T06:11:31.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects

**Official Title:** 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

**NCT ID:** [NCT01394224](https://clinicaltrials.gov/study/NCT01394224)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 25
- **Lead Sponsor:** UCB Pharma
- **Conditions:** Healthy Volunteers
- **Start Date:** 2011-06
- **Completion Date:** 2011-09
- **CT.gov Last Update:** 2011-10-06

## 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.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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

- **Levetiracetam IV Infusion (1500 mg)** (EXPERIMENTAL)
- **Levetiracetam tablets (1500 mg)** (EXPERIMENTAL)

## Interventions

- **Levetiracetam** (DRUG) — Strength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose
- **Levetiracetam** (DRUG) — Levetiracetam tablets Strength: 500 mg Form: Tablet Frequency: Single dose

## 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)** _(time frame: Multiple sampling from 0 to 36 hours following single dose)_
- **Plasma concentration at the end of infusion (C15' )** _(time frame: At 15 minutes after termination of the15-minutes infusion)_
- **Area under the curve from 0 to infinity (AUC)** _(time frame: Multiple sampling from 0 to 36 hours following single dose)_
- **Mean resident time (MRT)** _(time frame: Multiple sampling from 0 to 36 hours following single dose)_
- **Terminal elimination half-life(t1/2)** _(time frame: Multiple sampling from 0 to 36 hours following single dose)_
- **First order terminal elimination rate constant (λz )** _(time frame: Multiple sampling from 0 to 36 hours following single dose)_
- **Total body clearance after oral administration (CL/F) or after IV infusion (CL)** _(time frame: Multiple sampling from 0 to 36 hours following single dose)_
- **Volume of distribution after oral administration(Vz/F) or after IV infusion(Vz)** _(time frame: Multiple sampling from 0 to 36 hours following single dose)_

## Locations (1)

- London, United Kingdom

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|london||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01394224.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01394224*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*