Healthy Volunteers
Conditions
Keywords
Healthy volunteers, Japanese
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.
Interventions
DRUGLevetiracetam
Strength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum drug concentration (Cmax) | Multiple sampling from 0 to 36 hours following single dose |
| Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUCo-t) | 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
| Measure | Time frame |
|---|---|
| Area under the curve from 0 to infinity (AUC) | Multiple sampling from 0 to 36 hours following single dose |
| Mean resident time (MRT) | Multiple sampling from 0 to 36 hours following single dose |
| Terminal elimination half-life(t1/2) | Multiple sampling from 0 to 36 hours following single dose |
| Time to reach maximum plasma concentration (tmax) | Multiple sampling from 0 to 36 hours following single dose |
| Total body clearance after oral administration (CL/F) or after IV infusion (CL) | Multiple sampling from 0 to 36 hours following single dose |
| Volume of distribution after oral administration(Vz/F) or after IV infusion(Vz) | Multiple sampling from 0 to 36 hours following single dose |
| First order terminal elimination rate constant (λz ) | Multiple sampling from 0 to 36 hours following single dose |
| Plasma concentration at the end of infusion (C15' ) | At 15 minutes after termination of the15-minutes infusion |
Countries
United Kingdom
Outcome results
None listed