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Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet Formulation

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01027689
First Posted: December 9, 2009
Last Update Posted: May 30, 2012
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 (Responsible Party):
Pfizer
  Purpose
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing commercial immediate release tablet formulation.

Condition Intervention Phase
Healthy Drug: alprazolam commercial immediate release oral tablet Drug: alprazolam test sublingual tablet Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax) [ Time Frame: 11 days ]

Secondary Outcome Measures:
  • Alprazolam time of maximum concentration (Tmax) and half life [ Time Frame: 11 days ]
  • Adverse events, clinical laboratory tests, vital signs [ Time Frame: 11 days ]

Enrollment: 0
Study Start Date: April 2011
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Alprazolam commercial immediate release oral tablet Drug: alprazolam commercial immediate release oral tablet
1 mg tablet, single dose
Other Name: Xanax
Experimental: Alprazolam test sublingual tablet Drug: alprazolam test sublingual tablet
1 mg tablet, single dose

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female subjects
  • BMI 17.5 - 30.5
  • Must provide informed consent

Exclusion Criteria:

  • Clinically significant disease
  • Narrow angle glaucoma
  • Positive drug screen
  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): NCT01027689


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01027689     History of Changes
Other Study ID Numbers: A6131018
First Submitted: December 7, 2009
First Posted: December 9, 2009
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by Pfizer:
alprazolam
bioequivalence
sublingual

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