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To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg

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.
 
ClinicalTrials.gov Identifier: NCT00912145
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

Study Description
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Brief Summary:
To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg.

Condition or disease Intervention/treatment Phase
Anxiety Drug: Alprazolam Tablets, 2 mg (Geneva Pharmaceuticals, Inc.) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioavailability of Alprazolam Tablets, 2 mg.
Study Start Date : February 1996
Actual Primary Completion Date : February 1996
Actual Study Completion Date : February 1996

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Alprazolam

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Alprazolam Tablets, 2 mg (Geneva Pharmaceuticals, Inc.)
 Drug: Alprazolam Tablets, 2 mg (Geneva Pharmaceuticals, Inc.)
Active Comparator: 2
Alprazolam Tablets, 2 mg, Xanax (The Upjohn Company)
 Drug: Alprazolam Tablets, 2 mg (Geneva Pharmaceuticals, Inc.)


Outcome Measures
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Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 13 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
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.
Contacts and Locations
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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): NCT00912145


Sponsors and Collaborators
Sandoz
Investigators
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Principal Investigator: Calvin F. Fuhrmann, M.D. PharmaKinetics Laboratories Inc.
More Information
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Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00912145    
Other Study ID Numbers: 005-35-11034
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: June 2009
Additional relevant MeSH terms:
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Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
 Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action