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
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, see Learn About Clinical Studies.

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 July 24, 2014