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Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00827320
First Posted: January 22, 2009
Last Update Posted: January 22, 2009
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.
Information provided by:
Roxane Laboratories
  Purpose
The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets under fed conditions

Condition Intervention
Seizures Drug: Levetiracetam

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence based on Cmax [ Time Frame: 10 days ]

Enrollment: 26
Study Start Date: June 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Levetiracetam
    1000 mg tablet
    Other Name: KEPPRA
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Levetiracetam or any comparable or similar product.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00827320


Locations
United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Soran Hong, MD Novum Pharmaceutical Research Services
  More Information

Responsible Party: Elizabeth Ernst, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00827320     History of Changes
Other Study ID Numbers: LEVE-T1000-PVFD-1
First Submitted: January 15, 2009
First Posted: January 22, 2009
Last Update Posted: January 22, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs