Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet Formulation

Verified by: Pfizer, February 2011
First Received: December 7, 2009 | Last Updated: February 22, 2011 | Phase: Phase 1 | Start Date: April 2011
Overall Status: Withdrawn | Estimated Enrollment: 26
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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 an existing commercial immediate release tablet formulation...

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 Immediate Release Tablet”

This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing commercial immediate release tablet formulation.

  • 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: June 2011

Intervention(s) in this Clinical Trial

  • Drug: alprazolam commercial immediate release oral tablet
    • 1 mg tablet, single dose
  • Drug: alprazolam test sublingual tablet
    • 1 mg tablet, single dose

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Alprazolam commercial immediate release oral tablet
  • Experimental: Alprazolam test sublingual tablet

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  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01027689

Study ID Number: A6131018

ClinicalTrials.gov Identifier: NCT01027689

Health Authority: Mexico: Ministry of Health

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

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01027689