Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Levetiracetam
* Drug: Levetiracetam


Participation Criteria
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Eligibility Criteria
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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.

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: Levetiracetam IV Infusion (1500 mg)<br> | Drug: Levetiracetam<br>* Strength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose<br>* Other names: E-Keppra;|
| Experimental: Levetiracetam tablets (1500 mg)<br> | Drug: Levetiracetam<br>* Levetiracetam tablets Strength: 500 mg Form: Tablet Frequency: Single dose<br>* Other names: E-Keppra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach maximum plasma concentration (tmax) |  | 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 | 
| 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 | 
| First order terminal elimination rate constant (λz ) |  | 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 | 

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