A Study Of Two Oral Preparations Of 2 Mg Alprazolam In Healthy Volunteers Under Fasting Conditions

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

Overview

The purpose of this study is to compare bioavailability between formulations of alprazolam in tablets to determine their bioequivalence in terms of rate and magnitude of absorption.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Healthy

Interventions

AlprazolamDRUG

Single tablet

AlprazolamDRUG

Single tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers (male or female) * Age between 18-40 years * body mass index (Quetelet´s index) between 18-27 Exclusion Criteria: * Unhealthy subjects * Volunteers who require any medication over the course of the study * Volunteers who have received investigational drugs within 60 days prior to the study

Outcomes

Primary Outcomes

Establish Cmax, Tmax, elimination half life, area below the curve from zero to t, and area below the curve from zero to infinity (ABC 0-∞) of the two formulations of Alprazolam.

Time frame: 10 days

Statistically compare the bioavailability of the pharmaceutical formulations of Alprazolam studied, to establish or rule out the existence of bioequivalence.

Time frame: 10 days

Secondary Outcomes

Investigate the safety of both preparations based on the record of adverse events on completing both study periods.

Time frame: 10 days

Data from ClinicalTrials.gov

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