A Bioequivalence Study of Levetiracetam Versus Keppra

June 22, 2009 updated by: Tri-Service General Hospital

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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCPE08034M1
  • TSGHIRB097-02-006
  • C159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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