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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01618903
First received: June 11, 2012
Last updated: August 2, 2012
Last verified: August 2012

June 11, 2012
August 2, 2012
May 2012
July 2012   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Maximum measured plasma concentration (Cmax) [ Time Frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration ] [ Designated as safety issue: No ]
    The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.
Same as current
Complete list of historical versions of study NCT01618903 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
  • Terminal half-life of Levetiracetam (t1/2) [ Time Frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]

    The CL(iv) is calculated as:

    CL=Dose of LEV/AUC.

  • 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 ] [ Designated as safety issue: No ]

    The CL/F (tablet) is calculated as:

    CL/F=Dose of LEV/AUC.

  • 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 ] [ Designated as safety issue: No ]

    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.

  • 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 ] [ Designated as safety issue: No ]

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

    Vz/F= (CL/F)/λ_z.

Same as current
Not Provided
Not Provided
 
An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Human Volunteers
  • Drug: 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.
    Other Name: Keppra
  • Drug: Levetiracetam
    Levetiracetam single oral administration of 3 tablets of 500 mg immediate release tablet.
    Other Name: Keppra
  • Experimental: Levetiracetam iv infusion
    Levetiracetam intravenous (iv) 45 min infusion administered as one single dose.
    Intervention: Drug: Levetiracetam
  • Experimental: Levetiracetam oral tablet
    Levetiracetam oral tablet administered as one single dose.
    Intervention: Drug: Levetiracetam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01618903
N01362A
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP