Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01285505
First received: January 26, 2011
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.


Condition Intervention Phase
Healthy
Drug: alprazolam commercial sublingual formulation
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 An Alprazolam Sublingual Tablet

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC) [ Time Frame: 11 days ] [ Designated as safety issue: No ]
  • Alprazolam bioavailability as assessed by peak concentration (Cmax) [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alprazolam time of maximum concentration (Tmax) [ Time Frame: 11 days ] [ Designated as safety issue: No ]
  • Half life of alprazolam [ Time Frame: 11 days ] [ Designated as safety issue: No ]
  • Clinically significant safety laboratory tests [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
  • Clinically significant adverse events [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
  • Clinically significant vital signs [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
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 sublingual tablet Drug: alprazolam commercial sublingual formulation
0.5 mg tablet, single dose
Experimental: Alprazolam test sublingual tablet Drug: alprazolam test sublingual tablet
0.5 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 18 to 26.9
  • must give 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: NCT01285505

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: NCT01285505     History of Changes
Other Study ID Numbers: A6131020
Study First Received: January 26, 2011
Last Updated: April 7, 2011
Health Authority: Mexico: Ministry of Health

Keywords provided by Pfizer:
alprazolam
sublingual
bioequivalence

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 17, 2014