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

Viatris

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: alprazolam commercial immediate release oral tablet; Drug: alprazolam test sublingual tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01027689

A6131018

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Alprazolam commercial immediate release oral tablet

Active Comparator group

Treatment:

Drug: alprazolam commercial immediate release oral tablet

Alprazolam test sublingual tablet

Experimental group

Treatment:

Drug: alprazolam test sublingual tablet