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To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00912145
First received: June 2, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 2, 2009
June 2, 2009
February 1996
February 1996   (final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 13 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg
Bioavailability of Alprazolam Tablets, 2 mg.

To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Anxiety
Drug: Alprazolam Tablets, 2 mg (Geneva Pharmaceuticals, Inc.)
  • Experimental: 1
    Alprazolam Tablets, 2 mg (Geneva Pharmaceuticals, Inc.)
    Intervention: Drug: Alprazolam Tablets, 2 mg (Geneva Pharmaceuticals, Inc.)
  • Active Comparator: 2
    Alprazolam Tablets, 2 mg, Xanax (The Upjohn Company)
    Intervention: Drug: Alprazolam Tablets, 2 mg (Geneva Pharmaceuticals, Inc.)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
February 1996
February 1996   (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.
Male
19 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00912145
005-35-11034
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
Not Provided
Principal Investigator: Calvin F. Fuhrmann, M.D. PharmaKinetics Laboratories, Inc.
Sandoz
June 2009

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