Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fed Conditions

This study has been completed.
Information provided by:
Roxane Laboratories Identifier:
First received: January 16, 2009
Last updated: January 21, 2009
Last verified: January 2009
The objective of this study was to prove the bioequivalence of Levetiracetam 750 mg Tablets under fed conditions

Condition Intervention
Drug: Levetiracetam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fed Conditions

Resource links provided by NLM:

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalance based on Cmax [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: August 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Levetiracetam
    750 mg tablet
    Other Name: KEPPRA

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT00826787

United States, Arizona
MDS Pharma Services
Phoenix, Arizona, United States, 85044
Sponsors and Collaborators
Roxane Laboratories
Principal Investigator: Mark Allison, MD MDS Pharma Services
  More Information

Responsible Party: Elizabeth Ernst, Roxane Laboratories, Inc. Identifier: NCT00826787     History of Changes
Other Study ID Numbers: LEVE-T750-PVFD-1 
Study First Received: January 16, 2009
Last Updated: January 21, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neuroprotective Agents
Nootropic Agents
Physiological Effects of Drugs
Protective Agents processed this record on May 30, 2016