Human Pharmacology Study (Keppra Dry Syrup Bioequivalence Study)

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Monocenter, Open Label, Two-way Cross-over, Single Dose Bioequivalence Study of Two Oral Formulations of Levetiracetam in Healthy Male & Female Japanese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Levetiracetam (Keppra)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1/Treatment 2<br> | Drug: Levetiracetam (Keppra)<br>* Test Drug : Levetiracetam dry syrup Reference Drug : 500 mg oral tablets of Levetiracetam. Frequency: Single Dose<br>* Other names: Keppra;|
| Experimental: Treatment 2/Treatment 1<br> | Drug: Levetiracetam (Keppra)<br>* Test Drug : Levetiracetam dry syrup Reference Drug : 500 mg oral tablets of Levetiracetam. Frequency: Single Dose<br>* Other names: Keppra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax (time of maximum plasma concentration) of Levetiracetam |  | 36 hours | 
| λz (Terminal elimination rate constant) of Levetiracetam |  | 36 hours | 
| t1/2 (Terminal elimination half-life) of Levetiracetam |  | 36 hours | 
| MRT (Mean Residence Time) of Levetiracetam |  | 36 hours | 
| CL/F (Apparent total body clearance) of Levetiracetam |  | 36 hours | 
| Vz/F (Apparent volume of distribution) of Levetiracetam |  | 36 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levetiracetam, Healthy volunteers, Healthy Subjects