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To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00912145
First Posted: June 3, 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
  Purpose
To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioavailability of Alprazolam Tablets, 2 mg.

Resource links provided by NLM:


Further study details as provided by Sandoz:

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

Enrollment: 26
Study Start Date: February 1996
Study Completion Date: February 1996
Primary Completion Date: February 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.)

  Eligibility

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
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
Principal Investigator: Calvin F. Fuhrmann, M.D. PharmaKinetics Laboratories Inc.
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00912145     History of Changes
Other Study ID Numbers: 005-35-11034
First Submitted: June 2, 2009
First Posted: June 3, 2009
Last Update Posted: March 28, 2017
Last Verified: June 2009

Additional relevant MeSH terms:
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