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

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ClinicalTrials.gov Identifier: NCT01027689
Recruitment Status : Withdrawn
First Posted : December 9, 2009
Last Update Posted : May 30, 2012
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 an existing commercial immediate release tablet formulation.

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

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 Immediate Release Tablet
Study Start Date : April 2011
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Alprazolam

Arm Intervention/treatment
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




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:   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): NCT01027689


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01027689     History of Changes
Other Study ID Numbers: A6131018
First Posted: December 9, 2009    Key Record Dates
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