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An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese

NCT ID: NCT01618903

Last Updated: 2012-08-03

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-07-31

Brief Summary

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The part A of N01362 is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to tablet oral administration in Chinese healthy volunteers.

Detailed Description

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The study includes 2 parts, part A is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to oral tablet, part B is to assess pharmacokinetic profile of LEV infusion during repeated dosing in Chinese healthy volunteers.

Conditions

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Human Volunteers

Keywords

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Keppra Levetiracetam intravenous Oral tablets Bioequivalence Pharmacokinetics Safety Chinese healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levetiracetam iv infusion

Levetiracetam intravenous (iv) 45 min infusion administered as one single dose.

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

Levetiracetam 1.500 mg (500 mg/ 5 mL vials) administered as a 45 minutes intravenous infusion diluted in 100 mL 0.9 % saline solution in the morning of Day 1.

Levetiracetam oral tablet

Levetiracetam oral tablet administered as one single dose.

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

Levetiracetam single oral administration of 3 tablets of 500 mg immediate release tablet.

Interventions

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Levetiracetam

Levetiracetam 1.500 mg (500 mg/ 5 mL vials) administered as a 45 minutes intravenous infusion diluted in 100 mL 0.9 % saline solution in the morning of Day 1.

Intervention Type DRUG

Levetiracetam

Levetiracetam single oral administration of 3 tablets of 500 mg immediate release tablet.

Intervention Type DRUG

Other Intervention Names

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Keppra Keppra

Eligibility Criteria

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Inclusion Criteria

* Chinese, age 18-40, weight ≥ 50 kg
* Healthy volunteers with normal vital signs, good physical and mental health status and normal electrocardiogram and laboratory test

Exclusion Criteria

* History or presence of each systems disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication
* History or presence of drug addiction or excessive use of alcohol
* Symptomatic or asymptomatic Orthostatic Hypotension at screening
* Current smokers and former smokers
* Heavy caffeine drinker
* History of frequent and severe headache
* Any drug treatment
* Subjects who are known to have Serum Hepatitis or who are carriers of the Hepatitis B surface antigen, or Hepatitis C antibody or who are HIV positive
* Subjects on a controlled sodium diet
* Subject has made a blood donation or had a comparable blood loss
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 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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1

Shanghai, , China

Site Status

Countries

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China

Related Links

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http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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N01362A

Identifier Type: -

Identifier Source: org_study_id