A Bioequivalence Study of Levetiracetam Versus Keppra

NCT00926302 | Completed DMC

• 3 other identifiers: MCPE08034M1TSGHIRB097-02-006C159
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

The bioequivalence of Levetiracetam vs. Keppra; volunteer

Outcome Measures

Primary Outcomes (1)

• To assess the bioequivalence

  48 hours

Study Arms (2)

Test drug

EXPERIMENTAL

Levetiracetam one period

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

Reference drug

ACTIVE COMPARATOR

Keppra one period

Drug: Keppra (Levetiracetam - USB SA Pharma Sector)

Interventions

Levetiracetam (Lotus Pharmaceutical Co.,Ltd.) DRUG

Levetiracetam 500mg/tablet Oral once

Also known as: The test drug Levetiracetam is no brand name., Manufacturer:Lotus Pharmaceutical Co.,Ltd.

Test drug

Keppra (Levetiracetam - USB SA Pharma Sector) DRUG

Levetiracetam 500mg/tablet oral once

Also known as: Keppra, Manufracturer:USB SA Pharma Sector

Reference drug

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

MeSH Terms

Interventions

Levetiracetam

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• I-Shin Shiah, M.D.

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: June 23, 2009
• Study Start: January 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 23, 2009

Record last verified: 2009-06