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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.); Drug: Keppra (Levetiracetam - USB SA Pharma Sector)

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test drug; Levetiracetam one period	Drug: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.); Levetiracetam 500mg/tablet Oral once; Other Names: The test drug Levetiracetam is no brand name.; Manufacturer:Lotus Pharmaceutical Co.,Ltd.
Active Comparator: Reference drug; Keppra one period	Drug: Keppra (Levetiracetam - USB SA Pharma Sector); Levetiracetam 500mg/tablet oral once; Other Names: Keppra; Manufracturer:USB SA Pharma Sector

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the bioequivalence	48 hours

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Investigators: Principal Investigator: I-Shin Shiah, M.D., Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: June 18, 2009
• First Submitted That Met QC Criteria: June 22, 2009
• First Posted (Estimate): June 23, 2009

Study Record Updates

• Last Update Posted (Estimate): June 23, 2009
• Last Update Submitted That Met QC Criteria: June 22, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: volunteer; The bioequivalence of Levetiracetam vs. Keppra
• Additional Relevant MeSH Terms: Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: MCPE08034M1; TSGHIRB097-02-006; C159