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A Bioequivalence Study of Levetiracetam Versus Keppra

This study has been completed.
Sponsor:
Information provided by:
Tri-Service General Hospital
ClinicalTrials.gov Identifier:
NCT00926302
First received: June 18, 2009
Last updated: June 22, 2009
Last verified: June 2009

June 18, 2009
June 22, 2009
January 2008
February 2009   (final data collection date for primary outcome measure)
To assess the bioequivalence [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00926302 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • 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.
  • Drug: Keppra (Levetiracetam - USB SA Pharma Sector)
    Levetiracetam 500mg/tablet oral once
    Other Names:
    • Keppra
    • Manufracturer:USB SA Pharma Sector
  • Experimental: Test drug
    Levetiracetam one period
    Intervention: Drug: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)
  • Active Comparator: Reference drug
    Keppra one period
    Intervention: Drug: Keppra (Levetiracetam - USB SA Pharma Sector)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
April 2009
February 2009   (final data collection date for primary outcome measure)

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.
Male
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00926302
MCPE08034M1, TSGHIRB097-02-006, C159
Yes
I-Shin Shiah/The Head of Department of Psychiatry, Tri-Service General Hospital
Tri-Service General Hospital
Not Provided
Principal Investigator: I-Shin Shiah, M.D. Tri-Service General Hospital
Tri-Service General Hospital
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP