Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

Viatris

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: alprazolam commercial sublingual formulation; Drug: alprazolam test sublingual tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01285505

A6131020

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

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 sublingual tablet

Active Comparator group

Treatment:

Drug: alprazolam commercial sublingual formulation

Alprazolam test sublingual tablet

Experimental group

Treatment:

Drug: alprazolam test sublingual tablet