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

Viatris logo

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Withdrawn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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems