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To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 1 mg

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ClinicalTrials.gov Identifier: NCT00913341
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

Tracking Information
First Submitted Date  ICMJE June 2, 2009
First Posted Date  ICMJE June 4, 2009
Last Update Posted Date March 28, 2017
Study Start Date  ICMJE November 1991
Actual Primary Completion Date November 1991   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Bioequivalence based on AUC and Cmax [ Time Frame: 13 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 1 mg
Official Title  ICMJE Bioavailability of Alprazolam Tablets
Brief Summary To demonstrate the relative bioavailability of Alprazolam tablets, 1 mg.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anxiety
Intervention  ICMJE
  • Drug: Alprazolam Tablets, 1 mg (Geneva Pharmaceuticals)
  • Drug: Alprazolam Tablets, 1 mg (The Upjohn Company)
Study Arms  ICMJE
  • Experimental: 1
    Alprazolam Tablets, 1 mg (Geneva Pharmaceuticals)
    Intervention: Drug: Alprazolam Tablets, 1 mg (Geneva Pharmaceuticals)
  • Active Comparator: 2
    Alprazolam Tablets, 1 mg (The Upjohn Company)
    Intervention: Drug: Alprazolam Tablets, 1 mg (The Upjohn Company)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2009)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 1991
Actual Primary Completion Date November 1991   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00913341
Other Study ID Numbers  ICMJE 9153A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Study Sponsor  ICMJE Sandoz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Niloufar Guiv, M.D. PharmaKinetics Laboratories Inc.
PRS Account Sandoz
Verification Date June 2009

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