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

October 5, 2011 updated by: UCB Pharma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levetiracetam IV Infusion (1500 mg)
Drug: Levetiracetam
Strength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose
Other Names:
  • E-Keppra
Drug: Levetiracetam
Levetiracetam tablets Strength: 500 mg Form: Tablet Frequency: Single dose
Other Names:
  • E-Keppra
Experimental: Levetiracetam tablets (1500 mg)
Drug: Levetiracetam
Strength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose
Other Names:
  • E-Keppra
Drug: Levetiracetam
Levetiracetam tablets Strength: 500 mg Form: Tablet Frequency: Single dose
Other Names:
  • E-Keppra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum drug concentration (Cmax)
Time Frame: Multiple sampling from 0 to 36 hours following single dose
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
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 Outcome Measures

Outcome Measure
Time Frame
Time to reach maximum plasma concentration (tmax)
Time Frame: Multiple sampling from 0 to 36 hours following single dose
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
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
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
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
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
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
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
Multiple sampling from 0 to 36 hours following single dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

July 12, 2011

First Submitted That Met QC Criteria

July 13, 2011

First Posted (Estimate)

July 14, 2011

Study Record Updates

Last Update Posted (Estimate)

October 6, 2011

Last Update Submitted That Met QC Criteria

October 5, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01377
  • 2011-000827-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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