Clinical trial NCT01618877: A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers
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
Multiple dose
Safety
Pharmacokinetics
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: PARALLEL
Primary purpose: TREATMENT

Brief summary: The part B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg intravenous (iv) infusion during repeated dosing 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 the 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-time curve over a dosing interval (AUCτ)
timeFrame: Pharmacokinetic samples were taken 36 hours after iv administration on Day 7
measure: Maximum measured plasma concentration (Cmax)
timeFrame: Pharmacokinetic samples were taken 36 hours after iv administration on Day 7
Secondary outcomes:
measure: Plasma concentration at the end of the 45-minutes intravenous (iv) infusion (C45'(iv))
timeFrame: Pharmacokinetic samples were taken 36 hours after iv administration on Day 7
measure: Minimum plasma concentration over dosing interval after intravenous (iv) infusion (Cmin)
timeFrame: Pharmacokinetic samples were taken 36 hours after iv administration on Day 7
measure: Terminal half-life (t1/2)
timeFrame: Pharmacokinetic samples were taken 36 hours after iv administration on Day 7
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: