A Bioequivalence Study of Levetiracetam Versus Keppra

Study Overview
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Brief Summary
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The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra administered under fasting conditions to healthy adult subjects.

Detailed Description
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This study is a randomized, single, two-way crossover pivotal study. The pharmacokinetic blood samples and vital signs were obtained before and after administration at scheduled intervals as indicated in the study protocol.

Official Title
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A Randomized, Single, Two-Way Crossover Pivotal Study to Assess the Bioequivalence Study of Levetiracetam vs. Keppra Administered Under Fasting Conditions to Healthy Adult Subject

Conditions
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Healthy

Intervention / Treatment
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* Drug: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)
* Drug: Keppra (Levetiracetam - USB SA Pharma Sector)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study. Healthy adult male, aged between 20 and 40 years old. Body Mass Index between 18.5 and 25 (inclusive). Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram. No significant deviation from normal biochemistry examination. No significant deviation from normal hematology examination. No significant deviation from normal urinalysis examination. Exclusion Criteria: History of drug or alcohol abuse within the past year. Medical history of severe drug allergy or sensitivity to analogous drug. Evidence of acute or chronic disease or having undergone surgery from 4 weeks prior to Period I dosing. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology. Ongoing peptic ulcer and constipation. Planned vaccination during the time course of the study. Taking any clinical investigation drug from 2 months prior to Period I dosing. Use of any medication, including herb medicine or vitamins from 4 weeks before the study. Blood donation of more than 500 mL within the past 3 months. A positive Hepatitis B surface antigen or positive Hepatitis C antibody result. A positive test for HIV antibody.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

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: Test drug<br>Levetiracetam one period | Drug: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)<br>* Levetiracetam 500mg/tablet Oral once<br>* Other names: Manufacturer:Lotus Pharmaceutical Co.,Ltd.;|
| Active Comparator: Reference drug<br>Keppra one period | Drug: Keppra (Levetiracetam - USB SA Pharma Sector)<br>* Levetiracetam 500mg/tablet oral once<br>* Other names: Manufracturer:USB SA Pharma Sector;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the bioequivalence |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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The bioequivalence of Levetiracetam vs. Keppra, volunteer