Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation

Viatris

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00877955

A6131019

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 sublingual formulation expected to be used commercially in Brazil.

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)

---

0 participants in 2 patient groups

alprazolam sublingual tablet reference

Active Comparator group

Treatment:

Drug: alprazolam sublingual tablet commercial

alprazolam sublingual tablet test

Experimental group

Treatment:

Drug: alprazolam sublingual tablet test