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

NCT ID: NCT01394224

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Levetiracetam IV Infusion (1500 mg)

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

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

Levetiracetam tablets (1500 mg)

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

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

Interventions

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Levetiracetam

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

Intervention Type DRUG

Levetiracetam

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

Intervention Type DRUG

Other Intervention Names

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E-Keppra E-Keppra

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2011-000827-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

N01377

Identifier Type: -

Identifier Source: org_study_id