Official Title: “Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Sublingual Tablet”

This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from sublingual formulation expected to be used commercially in Brazil.

Study Type: Interventional

Study Design: Basic Science, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

• Drug: alprazolam sublingual tablet commercial
  • 0.5 mg sublingual tablet, single dose
• Drug: alprazolam sublingual tablet test
  • 0.5 mg tablet, single dose

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: alprazolam sublingual tablet reference
• Experimental: alprazolam sublingual tablet test

Primary Measures

• Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)
  • Time Frame: 11 days
    Safety Issue?: No

Secondary Measures

• Alprazolam time of maximum concentration (Tmax) and half life
  • Time Frame: 11 days
    Safety Issue?: No
• Adverse events, clinical laboratory tests, vital signs
  • Time Frame: 11 days
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00877955

Study ID Number: A6131019

ClinicalTrials.gov Identifier: NCT00877955

Health Authority: India: Drugs Controller General of India

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