A Bioequivalence Study of Levetiracetam Versus Keppra

NCT ID: NCT00926302

Last Updated: 2009-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-04-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Test drug

Levetiracetam one period

Group Type: EXPERIMENTAL

Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)

Intervention Type: DRUG

Levetiracetam 500mg/tablet Oral once

Reference drug

Keppra one period

Group Type: ACTIVE_COMPARATOR

Keppra (Levetiracetam - USB SA Pharma Sector)

Intervention Type: DRUG

Levetiracetam 500mg/tablet oral once

Interventions

Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)

Levetiracetam 500mg/tablet Oral once

Intervention Type: DRUG

Keppra (Levetiracetam - USB SA Pharma Sector)

Levetiracetam 500mg/tablet oral once

Intervention Type: DRUG

Other Intervention Names

The test drug Levetiracetam is no brand name.; Manufacturer:Lotus Pharmaceutical Co.,Ltd.; Keppra; Manufracturer:USB SA Pharma Sector

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tri-Service General Hospital

Principal Investigators

I-Shin Shiah, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Other Identifiers

TSGHIRB097-02-006

Identifier Type: -

Identifier Source: secondary_id

C159

Identifier Type: -

Identifier Source: secondary_id

MCPE08034M1

Identifier Type: -

Identifier Source: org_study_id