Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01256151
First received: December 6, 2010
Last updated: May 24, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Anxiety Disorder
Drug: Alprazolam tablet
Drug: Alprazolam sublingual
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area under the curve (AUC) from time zero to last measurable time of alprazolam [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Peak concentration of alprazolam [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the curve from time zero to infinity [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • AUC% extrapolated [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Time of Cmax [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • half-life of alprazolam [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Clinically significant safety laboratory tests [ Time Frame: Screening, Day 0, Day 4 ] [ Designated as safety issue: Yes ]
  • Clincally significant vital signs [ Time Frame: Screening, Day 4 ] [ Designated as safety issue: Yes ]
  • Clinically significant adverse events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: January 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01256151     History of Changes
Other Study ID Numbers: A6131024
Study First Received: December 6, 2010
Last Updated: May 24, 2011
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014