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Completed

NCT Number: NCT01618903

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

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.

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Key information

Conditions

Human Volunteers

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Levetiracetam

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.

Other names: Keppra

Primary outcomes

  1. Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable concentration (AUC(0-t))

    Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration

  2. Area under the plasma drug concentration-time curve from 0 to infinity (AUC)

    Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration

    The area under the curve extrapolated to infinity is calculated as the sum of AUC(0-t) and a residual part extrapolated to infinite time.

  3. Maximum measured plasma concentration (Cmax)

    Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration

    The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.

Secondary outcomes

  1. Area under the plasma drug concentration-time curve calculated from 0 to 12 h (AUC(0-12))

    Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration

  2. Plasma concentration at the end of the 45-minutes intravenous (iv) infusion (C45'(iv))

    Time frame: Pharmacokinetic samples were taken at 45 min after Levetiracetam administration

    The value of the plasma concentration at the end of the 45-min iv infusion is directly obtained from the experimental data of plasma concentration versus time curves.

  3. Time to reach the maximum plasma concentration of Levetiracetam after administration (tmax)

    Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration

  4. Terminal half-life of Levetiracetam (t1/2)

    Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration

    The terminal half-life associated with the terminal rate constant λ_z is calculated as: ln2/λ_z. λ_z is the first order rate constant of elimination.

  5. Total body clearance after intravenous infusion of Levetiracetam (CL(iv))

    Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration

    The CL(iv) is calculated as:

    CL=Dose of LEV/AUC.

  6. Apparent total body clearance after oral administration of Levetiracetam (CL/F(tablet))

    Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration

    The CL/F (tablet) is calculated as:

    CL/F=Dose of LEV/AUC.

  7. Volume of distribution after intravenous infusion of Levetiracetam (Vz(iv))

    Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration

    The volume of distribution after iv infusion is calculated as:

    Vz=CL/λ_z, where CL is the total body clearance and λ_z the first order rate constant of elimination.

  8. Apparent volume of distribution after oral administration of Levetiracetam (Vz/F(tablet))

    Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration

    The apparent volume of distribution after oral administration is calculated as:

    Vz/F= (CL/F)/λ_z.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Monocenter, Open-label, Two-way Randomized Cross-over Study to Evaluate the Bioequivalence of Levetiracetam Administered as a 45 Minutes Intravenous Infusion and Same Dosage Levetiracetam Oral Tablet (Part A); and a Randomized, Double-blind, Placebo-controlled, Parallel Study on the Safety, Tolerability and Pharmacokinetics of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of b.i.d. Dosing (Part B), in Chinese Healthy Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 13, 2012
Registry last updated
Aug 3, 2012

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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