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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: March 27, 2017
Last verified: June 2009
June 2, 2009
March 27, 2017
February 1996
February 1996   (Final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 13 days ]
Same as current
Complete list of historical versions of study NCT00912145 on ClinicalTrials.gov Archive Site
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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
Intervention Model: Crossover Assignment
Masking: None (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.)
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*   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.
Sexes Eligible for Study: Male
19 Years to 49 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00912145
005-35-11034
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Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz
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