Clinical trial NCT01618903: An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Volunteers
Keywords: Keppra Levetiracetam intravenous
Oral tablets
Bioequivalence
Pharmacokinetics
Safety
Chinese healthy volunteers
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-06-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable concentration (AUC(0-t))
timeFrame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
measure: Area under the plasma drug concentration-time curve from 0 to infinity (AUC)
timeFrame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
measure: Maximum measured plasma concentration (Cmax)
timeFrame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Secondary outcomes:
measure: Area under the plasma drug concentration-time curve calculated from 0 to 12 h (AUC(0-12))
timeFrame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
measure: Plasma concentration at the end of the 45-minutes intravenous (iv) infusion (C45'(iv))
timeFrame: Pharmacokinetic samples were taken at 45 min after Levetiracetam administration
measure: Time to reach the maximum plasma concentration of Levetiracetam after administration (tmax)
timeFrame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
measure: Terminal half-life of Levetiracetam (t1/2)
timeFrame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
measure: Total body clearance after intravenous infusion of Levetiracetam (CL(iv))
timeFrame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
measure: Apparent total body clearance after oral administration of Levetiracetam (CL/F(tablet))
timeFrame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
measure: Volume of distribution after intravenous infusion of Levetiracetam (Vz(iv))
timeFrame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
measure: Apparent volume of distribution after oral administration of Levetiracetam (Vz/F(tablet))
timeFrame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 1
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: