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Completed

NCT Number: NCT01394224

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levetiracetam

Drug

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

Other names: E-Keppra

Primary outcomes

  1. Maximum drug concentration (Cmax)

    Time frame: Multiple sampling from 0 to 36 hours following single dose

  2. 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

  1. Time to reach maximum plasma concentration (tmax)

    Time frame: Multiple sampling from 0 to 36 hours following single dose

  2. Plasma concentration at the end of infusion (C15' )

    Time frame: At 15 minutes after termination of the15-minutes infusion

  3. Area under the curve from 0 to infinity (AUC)

    Time frame: Multiple sampling from 0 to 36 hours following single dose

  4. Mean resident time (MRT)

    Time frame: Multiple sampling from 0 to 36 hours following single dose

  5. Terminal elimination half-life(t1/2)

    Time frame: Multiple sampling from 0 to 36 hours following single dose

  6. First order terminal elimination rate constant (λz )

    Time frame: Multiple sampling from 0 to 36 hours following single dose

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 14, 2011
Registry last updated
Oct 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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