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This study has been withdrawn prior to enrollment.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
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: 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 August 20, 2014