A Bioequivalence Study of Levetiracetam Versus Keppra

Tri-Service General Hospital

Status: Completed

Conditions: Healthy

Treatments: Drug: Keppra (Levetiracetam - USB SA Pharma Sector); Drug: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)

Study type: Interventional

Funder types: Other

Identifiers

NCT00926302

C159

MCPE08034M1

TSGHIRB097-02-006

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

26 participants in 2 patient groups

Test drug

Experimental group

Description:

Levetiracetam one period

Treatment:

Drug: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)

Reference drug

Active Comparator group

Description:

Keppra one period

Treatment:

Drug: Keppra (Levetiracetam - USB SA Pharma Sector)