A Bioequivalence Study of Levetiracetam Versus Keppra

A Randomized, Single, Two-Way Crossover Pivotal Study to Assess the Bioequivalence Study of Levetiracetam vs. Keppra Administered Under Fasting Conditions to Healthy Adult Subject

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00926302

Enrollment

Registered

2009-06-23

Start date

2008-01-31

Completion date

2009-04-30

Last updated

2009-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

The bioequivalence of Levetiracetam vs. Keppra, volunteer

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.

Interventions

DRUGLevetiracetam (Lotus Pharmaceutical Co.,Ltd.)

Levetiracetam 500mg/tablet Oral once

DRUGKeppra (Levetiracetam - USB SA Pharma Sector)

Levetiracetam 500mg/tablet oral once

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To assess the bioequivalence	48 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026