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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
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioavailability of Alprazolam Tablets, 2 mg.

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
Drug Information available for: Alprazolam
U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 13 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years to 49 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912145

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Calvin F. Fuhrmann, M.D. PharmaKinetics Laboratories, Inc.
  More Information

No publications provided

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
Study First Received: June 2, 2009
Last Updated: June 2, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013