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Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation

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.
 
ClinicalTrials.gov Identifier: NCT00877955
Recruitment Status : Withdrawn
First Posted : April 8, 2009
Last Update Posted : March 12, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from sublingual formulation expected to be used commercially in Brazil.

Condition or disease Intervention/treatment Phase
Healthy Drug: alprazolam sublingual tablet commercial Drug: alprazolam sublingual tablet test Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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 Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Sublingual Tablet
Study Start Date : September 2012
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Alprazolam

Arm Intervention/treatment
Active Comparator: alprazolam sublingual tablet reference Drug: alprazolam sublingual tablet commercial
0.5 mg sublingual tablet, single dose

Experimental: alprazolam sublingual tablet test Drug: alprazolam sublingual tablet test
0.5 mg tablet, single dose




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

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.


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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

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): NCT00877955


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00877955    
Other Study ID Numbers: A6131019
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: March 2015
Keywords provided by Pfizer:
bioequivalence
pharmacokinetic
alprazolam
sublingual
Additional relevant MeSH terms:
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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