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To Demonstrate the Relative Bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00946751
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

Brief Summary:
To demonstrate the relative bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam tablets in healthy adult volunteers under fasting conditions.

Condition or disease Intervention/treatment Phase
Seizure Drug: Levetiracetam Tablets, 750 mg (Sandoz Inc.) Drug: Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions
Study Start Date : March 2004
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Levetiracetam Tablets, 750 mg (Sandoz Inc.)
Drug: Levetiracetam Tablets, 750 mg (Sandoz Inc.)
Active Comparator: 2
Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)
Drug: Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 10 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

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): NCT00946751


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Gaetano Morelli, M.D. MDS Pharma Services

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00946751     History of Changes
Other Study ID Numbers: AA15241
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: July 2009

Keywords provided by Sandoz:
Anticonvulsant

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