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A Bioequivalence Study of Levetiracetam Versus Keppra

Sponsor
Tri-Service General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00926302
Collaborator
(none)
26
Enrollment
2
Arms
15
Duration (Months)

Study Details

Study Description

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
  • Drug: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)
  • Drug: Keppra (Levetiracetam - USB SA Pharma Sector)
 N/A

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 Design

Study Type:
Interventional
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 :
Jan 1, 2008
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Apr 1, 2009

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To assess the bioequivalence [48 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tri-Service General Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00926302
    Other Study ID Numbers:
    • MCPE08034M1
    • TSGHIRB097-02-006
    • C159
    First Posted:
    Jun 23, 2009
    Last Update Posted:
    Jun 23, 2009
    Last Verified:
    Jun 1, 2009
    Keywords provided by , ,
    The bioequivalence of Levetiracetam vs. Keppra
    volunteer
    Additional relevant MeSH terms:
    Levetiracetam

    Study Results

    No Results Posted as of Jun 23, 2009