A Bioequivalence Study of Levetiracetam Versus Keppra

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.); Drug: Keppra (Levetiracetam - USB SA Pharma Sector)

• Registration Number: NCT00926302
• Lead Sponsor: Tri-Service General Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-02
• Study Completion: 2009-04
• Status Verified: 2009-06
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-22
• Last Update Submitted: 2009-06-22
• Study First Posted: 2009-06-23
• Last Update Posted: 2009-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

1. 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.
2. Healthy adult male, aged between 20 and 40 years old.
3. Body Mass Index between 18.5 and 25 (inclusive).
4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
5. No significant deviation from normal biochemistry examination.
6. No significant deviation from normal hematology examination.
7. No significant deviation from normal urinalysis examination.

Exclusion Criteria

1. History of drug or alcohol abuse within the past year.
2. Medical history of severe drug allergy or sensitivity to analogous drug.
3. Evidence of acute or chronic disease or having undergone surgery from 4 weeks prior to Period I dosing.
4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
5. Ongoing peptic ulcer and constipation.
6. Planned vaccination during the time course of the study.
7. Taking any clinical investigation drug from 2 months prior to Period I dosing.
8. Use of any medication, including herb medicine or vitamins from 4 weeks before the study.
9. Blood donation of more than 500 mL within the past 3 months.
10. A positive Hepatitis B surface antigen or positive Hepatitis C antibody result.
11. A positive test for HIV antibody.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test drug	Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)	Levetiracetam one period
Reference drug	Keppra (Levetiracetam - USB SA Pharma Sector)	Keppra one period

Primary Outcome Measures

Name	Time	Method
To assess the bioequivalence	48 hours