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This study has been withdrawn prior to enrollment.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
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: 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 October 16, 2014