Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation

Verified by: Pfizer, April 2011
First Received: April 7, 2009 | Last Updated: April 26, 2011 | Phase: Phase 1 | Start Date: September 2012
Overall Status: Not yet recruiting | Estimated Enrollment: 24
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
  • Study Primary Completion Date: October 2012

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

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 

Additional Information

Information obtained from ClinicalTrials.gov on February 02, 2012

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

To obtain contact information for a study center near you, click here.

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