Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

This study has been withdrawn prior to enrollment.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


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01285505

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. 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:

Additional relevant MeSH terms:
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on February 04, 2016