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A Bioequivalence Study of Levetiracetam Versus Keppra

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00926302
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : June 23, 2009
Information provided by:
Tri-Service General Hospital

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.) Drug: Keppra (Levetiracetam - USB SA Pharma Sector) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : January 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. To assess the bioequivalence [ Time Frame: 48 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00926302

Sponsors and Collaborators
Tri-Service General Hospital
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Principal Investigator: I-Shin Shiah, M.D. Tri-Service General Hospital

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Responsible Party: I-Shin Shiah/The Head of Department of Psychiatry, Tri-Service General Hospital Identifier: NCT00926302     History of Changes
Other Study ID Numbers: MCPE08034M1
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: June 23, 2009
Last Verified: June 2009
Keywords provided by Tri-Service General Hospital:
The bioequivalence of Levetiracetam vs. Keppra
Additional relevant MeSH terms:
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Nootropic Agents