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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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014