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Bioequivalence of Alprazolam Sublingual vs Oral Tablets

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00860119
First Posted: March 11, 2009
Last Update Posted: November 13, 2009
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:
Pfizer
  Purpose
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from a standard orally administered tablet.

Condition Intervention Phase
Healthy Drug: alprazolam sublingual tablet Drug: alprazolam oral 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 Pivotal Bioequivalence Study Comparing Alprazolam Immediate Release (IR) Tablets (Administered Orally) And Alprazolam Sublingual (SL) Tablets (Administered Sublingually)

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: 23
Study Start Date: August 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sublingual tablet
Test treatment
Drug: alprazolam sublingual tablet
1 mg alprazolam sublingual tablet, given as a single dose to each subject
Experimental: Oral tablet
Reference treatment
Drug: alprazolam oral tablet
1 mg alprazolam immediate release oral tablet, given as a single dose to each subject
Other Name: Xanax

  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:   21 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): NCT00860119


Locations
India
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 015
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00860119     History of Changes
Other Study ID Numbers: A6131017
First Submitted: March 10, 2009
First Posted: March 11, 2009
Last Update Posted: November 13, 2009
Last Verified: November 2009

Keywords provided by Pfizer:
Bioequivalence, Pharmacokinetics, Alprazolam, 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