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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00946751
First Posted: July 27, 2009
Last Update Posted: March 28, 2017
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:
Sandoz
July 24, 2009
July 27, 2009
March 28, 2017
March 2004
March 2004   (Final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 10 days ]
Same as current
Complete list of historical versions of study NCT00946751 on ClinicalTrials.gov Archive Site
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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
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
To demonstrate the relative bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam tablets in healthy adult volunteers under fasting conditions.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Seizure
  • Drug: Levetiracetam Tablets, 750 mg (Sandoz Inc.)
  • Drug: Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)
  • Experimental: 1
    Levetiracetam Tablets, 750 mg (Sandoz Inc.)
    Intervention: Drug: Levetiracetam Tablets, 750 mg (Sandoz Inc.)
  • Active Comparator: 2
    Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)
    Intervention: Drug: Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2004
March 2004   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00946751
AA15241
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Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz
Not Provided
Principal Investigator: Gaetano Morelli, M.D. MDS Pharma Services
Sandoz
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP