Status:
COMPLETED
A Bioequivalence Study of Levetiracetam Versus Keppra
Lead Sponsor:
Tri-Service General Hospital
Conditions:
Healthy
Eligibility:
MALE
20-40 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00926302
Start Date
January 1 2008
End Date
April 1 2009
Last Update
June 23 2009
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