Text Size

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
History of Changes
  Purpose

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


Condition Intervention
Healthy
 Drug: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)
Drug: Keppra (Levetiracetam - USB SA Pharma Sector)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tri-Service General Hospital:

Primary Outcome Measures:
  • To assess the bioequivalence [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: January 2008
Study Completion Date: April 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00926302

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

No publications provided

Responsible Party: I-Shin Shiah/The Head of Department of Psychiatry, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT00926302     History of Changes
Other Study ID Numbers: MCPE08034M1, TSGHIRB097-02-006, C159
Study First Received: June 18, 2009
Last Updated: June 22, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Tri-Service General Hospital:
The bioequivalence of Levetiracetam vs. Keppra
volunteer

Additional relevant MeSH terms:
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013