Bioequivalence of Alprazolam Sublingual vs Oral Tablets

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: alprazolam oral tablet; Drug: alprazolam sublingual tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00860119

A6131017

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 a standard orally administered tablet.

Enrollment: 23 patients

Sex: All

Ages: 21 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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23 participants in 2 patient groups

Sublingual tablet

Experimental group

Description:

Test treatment

Treatment:

Drug: alprazolam sublingual tablet

Oral tablet

Experimental group

Description:

Reference treatment

Treatment:

Drug: alprazolam oral tablet