Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00827320
First received: January 15, 2009
Last updated: January 21, 2009
Last verified: January 2009
  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
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 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Elizabeth Ernst, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00827320     History of Changes
Other Study ID Numbers: LEVE-T1000-PVFD-1
Study First Received: January 15, 2009
Last Updated: January 21, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
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 April 17, 2014