A Bioequivalence Study of Levetiracetam Versus Keppra

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.

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.