Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Overview

This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Healthy

Interventions

alprazolam commercial sublingual formulationDRUG

0.5 mg tablet, single dose

alprazolam test sublingual tabletDRUG

0.5 mg tablet, single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy male or female subjects * BMI 18 to 26.9 * must give informed consent Exclusion Criteria: * clinically significant disease * narrow angle glaucoma * positive drug screen

Outcomes

Primary Outcomes

Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC)

Time frame: 11 days

Alprazolam bioavailability as assessed by peak concentration (Cmax)

Time frame: 11 days

Secondary Outcomes

Alprazolam time of maximum concentration (Tmax)

Time frame: 11 days

Half life of alprazolam

Time frame: 11 days

Clinically significant safety laboratory tests

Time frame: 11 days

Clinically significant adverse events

Time frame: 11 days

Clinically significant vital signs

Time frame: 11 days

Data from ClinicalTrials.gov

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