Bioequivalence of Alprazolam Sublingual vs Oral Tablets

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. Identifier: NCT00860119
Recruitment Status : Completed
First Posted : March 11, 2009
Last Update Posted : November 13, 2009
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Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: alprazolam sublingual tablet Drug: alprazolam oral tablet Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
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)
Study Start Date : August 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Alprazolam

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00860119

Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 015
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

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

Keywords provided by Pfizer:
Bioequivalence, Pharmacokinetics, Alprazolam, Sublingual

Additional relevant MeSH terms:
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