Healthy
Conditions
Keywords
Levetiracetam, Healthy volunteers, Healthy Subjects
Brief summary
To demonstrate the bioequivalence of a Levetiracetam dry syrup (50% (500mg/1000mg)) versus Levetiracetam 500 mg oral tablet, used as reference, after single dose administration in healthy Japanese subjects.
Interventions
Test Drug : Levetiracetam dry syrup Reference Drug : 500 mg oral tablets of Levetiracetam. 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
* Written informed consent dated and signed by subject. * Healthy male or female Japanese volunteer from the first generation, living outside of Japan for less than 10 years, age range 20 to 55 years inclusive. * Body Mass Index (BMI) between 18.0 and 28.0 kg/m² inclusive.
Exclusion criteria
* Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method. * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, neurological, psychiatric disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication. * History of drug addiction or presence of drug addiction (positive drug screen) or excessive use of alcohol (weekly intake in excess of 21 units alcohol for male and 14 units alcohol for female; one unit alcohol equals one glass of beer or lager, a glass of wine or a measure of spirits), of psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements. * Heavy caffeine drinker (drinking \>5 cups of coffee or equivalent, approximately 500mg of caffeine per day). * Smokers of more than 10 cigarettes per day or smokers not willing to abstain from smoking while in the clinic for each period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax (maximum plasma concentration) of Levetiracetam. | 36 hours |
| AUC (0-t) (Area under the plasma concentration vs. time curve observed from time 0 h up to the last measurable data point) of Levetiracetam | 36 hours |
| AUC (Area under the curve extrapolated to infinity) of Levetiracetam | 36 hours |
Secondary
| Measure | Time frame |
|---|---|
| MRT (Mean Residence Time) of Levetiracetam | 36 hours |
| tmax (time of maximum plasma concentration) of Levetiracetam | 36 hours |
| Vz/F (Apparent volume of distribution) of Levetiracetam | 36 hours |
| CL/F (Apparent total body clearance) of Levetiracetam | 36 hours |
| λz (Terminal elimination rate constant) of Levetiracetam | 36 hours |
| t1/2 (Terminal elimination half-life) of Levetiracetam | 36 hours |
Countries
United Kingdom
Outcome results
None listed