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

Viatris logo

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Withdrawn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)

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems