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A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers

NCT ID: NCT01618877

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 B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg intravenous (iv) infusion during repeated dosing 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 the 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 Multiple dose Safety Pharmacokinetics Chinese healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Levetiracetam iv infusion

Levetiracetam intravenous (iv) infusion.

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 every 12 hours from the morning of Day 3 (it is the first day in Part B) to the morning of Day 7 (it is the 5th day in Part B).

Placebo infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

15 mL 0.9 % saline solution added to 100 mL 0.9 % saline solution, administered as a 45 minutes intravenous infusion every 12 hours from the morning of Day 3 ( it is the 1st day in Part B) to the morning of Day 7 (it is the 5th day in Part B).

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 every 12 hours from the morning of Day 3 (it is the first day in Part B) to the morning of Day 7 (it is the 5th day in Part B).

Intervention Type DRUG

Placebo

15 mL 0.9 % saline solution added to 100 mL 0.9 % saline solution, administered as a 45 minutes intravenous infusion every 12 hours from the morning of Day 3 ( it is the 1st day in Part B) to the morning of Day 7 (it is the 5th day in Part B).

Intervention Type OTHER

Other Intervention Names

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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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N01362B

Identifier Type: -

Identifier Source: org_study_id