Clinical trial NCT01394224: Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Japanese
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-07-14
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum drug concentration (Cmax)
timeFrame: Multiple sampling from 0 to 36 hours following single dose
measure: Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUCo-t)
timeFrame: 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:
measure: Time to reach maximum plasma concentration (tmax)
timeFrame: Multiple sampling from 0 to 36 hours following single dose
measure: Plasma concentration at the end of infusion (C15' )
timeFrame: At 15 minutes after termination of the15-minutes infusion
measure: Area under the curve from 0 to infinity (AUC)
timeFrame: Multiple sampling from 0 to 36 hours following single dose
measure: Mean resident time (MRT)
timeFrame: Multiple sampling from 0 to 36 hours following single dose
measure: Terminal elimination half-life(t1/2)
timeFrame: Multiple sampling from 0 to 36 hours following single dose
measure: First order terminal elimination rate constant (λz )
timeFrame: Multiple sampling from 0 to 36 hours following single dose
measure: Total body clearance after oral administration (CL/F) or after IV infusion (CL)
timeFrame: Multiple sampling from 0 to 36 hours following single dose
measure: Volume of distribution after oral administration(Vz/F) or after IV infusion(Vz)
timeFrame: Multiple sampling from 0 to 36 hours following single dose
Other outcomes:
Locations:
city: London
country: United Kingdom
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: