Clinical trial NCT00985348: Human Pharmacology Study (Keppra Dry Syrup Bioequivalence Study)
Official title: Randomized, Monocenter, Open Label, Two-way Cross-over, Single Dose Bioequivalence Study of Two Oral Formulations of Levetiracetam in Healthy Male & Female Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Levetiracetam
Healthy volunteers
Healthy Subjects
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2009-09-28
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cmax (maximum plasma concentration) of Levetiracetam.
timeFrame: 36 hours
measure: 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
timeFrame: 36 hours
measure: AUC (Area under the curve extrapolated to infinity) of Levetiracetam
timeFrame: 36 hours
Secondary outcomes:
measure: tmax (time of maximum plasma concentration) of Levetiracetam
timeFrame: 36 hours
measure: λz (Terminal elimination rate constant) of Levetiracetam
timeFrame: 36 hours
measure: t1/2 (Terminal elimination half-life) of Levetiracetam
timeFrame: 36 hours
measure: MRT (Mean Residence Time) of Levetiracetam
timeFrame: 36 hours
measure: CL/F (Apparent total body clearance) of Levetiracetam
timeFrame: 36 hours
measure: Vz/F (Apparent volume of distribution) of Levetiracetam
timeFrame: 36 hours
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: