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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2011

Interventions

  • 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

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

Clinical Trial Outcome Measures

Primary Measures

  • Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)
    • Time Frame: 11 days

Secondary Measures

  • Alprazolam time of maximum concentration (Tmax) and half life
    • Time Frame: 11 days
  • Adverse events, clinical laboratory tests, vital signs
    • Time Frame: 11 days

Participating 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: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer’s Upjohn has merged with Mylan to form Viatris Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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