Bioequivalence of Alprazolam Sublingual vs Oral Tablets

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00860119
First received: March 10, 2009
Last updated: November 11, 2009
Last verified: November 2009
  Purpose

This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from a standard orally administered tablet.


Condition Intervention Phase
Healthy
Drug: alprazolam sublingual tablet
Drug: alprazolam oral tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Open-Label, Randomized, Single-Dose, 2-Way Crossover Pivotal Bioequivalence Study Comparing Alprazolam Immediate Release (IR) Tablets (Administered Orally) And Alprazolam Sublingual (SL) Tablets (Administered Sublingually)

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: 23
Study Start Date: August 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sublingual tablet
Test treatment
Drug: alprazolam sublingual tablet
1 mg alprazolam sublingual tablet, given as a single dose to each subject
Experimental: Oral tablet
Reference treatment
Drug: alprazolam oral tablet
1 mg alprazolam immediate release oral tablet, given as a single dose to each subject
Other Name: Xanax

  Eligibility

Ages Eligible for Study:   21 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: NCT00860119

Locations
India
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 015
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: NCT00860119     History of Changes
Other Study ID Numbers: A6131017
Study First Received: March 10, 2009
Last Updated: November 11, 2009
Health Authority: India: Drugs Controller General of India

Keywords provided by Pfizer:
Bioequivalence, Pharmacokinetics, Alprazolam, 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 September 30, 2014