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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01027689
First received: December 7, 2009
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Healthy
Drug: alprazolam commercial immediate release oral tablet
Drug: alprazolam test sublingual tablet
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:
  • Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax) [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alprazolam time of maximum concentration (Tmax) and half life [ Time Frame: 11 days ] [ Designated as safety issue: No ]
  • Adverse events, clinical laboratory tests, vital signs [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: April 2011
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027689

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01027689     History of Changes
Other Study ID Numbers: A6131018
Study First Received: December 7, 2009
Last Updated: May 29, 2012
Health Authority: Mexico: Ministry of Health

Keywords provided by Pfizer:
alprazolam
bioequivalence
sublingual

Additional relevant MeSH terms:
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 16, 2014