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Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet

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ClinicalTrials.gov Identifier: NCT01256151
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : May 26, 2011
Sponsor:
Information provided by:
Pfizer

Brief Summary:
To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.

Condition or disease Intervention/treatment Phase
Anxiety Disorder Drug: Alprazolam tablet Drug: Alprazolam sublingual Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 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 : January 2011
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Alprazolam
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Alprazolam conventional tablet
Alprazolam conventional tablet
Drug: Alprazolam tablet
1 mg single dose of alprazolam conventional tablet
Experimental: Alprazolam sublingual tablet
Alprazolam sublingual tablet
Drug: Alprazolam sublingual
1 mg single dose of alprazolam sublingual tablet



Primary Outcome Measures :
  1. Area under the curve (AUC) from time zero to last measurable time of alprazolam [ Time Frame: 72 hours ]
  2. Peak concentration of alprazolam [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Area under the curve from time zero to infinity [ Time Frame: 72 hours ]
  2. AUC% extrapolated [ Time Frame: 72 hours ]
  3. Time of Cmax [ Time Frame: 72 hours ]
  4. half-life of alprazolam [ Time Frame: 72 hours ]
  5. Clinically significant safety laboratory tests [ Time Frame: Screening, Day 0, Day 4 ]
  6. Clincally significant vital signs [ Time Frame: Screening, Day 4 ]
  7. Clinically significant adverse events [ Time Frame: 1 month ]


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 and/or female subjects between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
  • Signed informed consent.

Exclusion Criteria:

  • Evidence or history of clinically significant abnormalities
  • Positive drug screen, excessive alcohol and tobacco use

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): NCT01256151


Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01256151     History of Changes
Other Study ID Numbers: A6131024
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: May 26, 2011
Last Verified: May 2011

Keywords provided by Pfizer:
Bioequivalence
sublingual
alprazolam
pharmacokinetics

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
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