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Bioequivalence Study of Tiotropium Bromide Inhalation Powder

COPD Clinical Trial

Official title:
Multicentre,Randomized,Double-Blind,Double-Dummy,3period,6Seq,Crossover,Active&Placebo,SD PD Study to Evaluate Therapeutic Equivalence of Test Tiotropium Bromide Inh. Powder to Reference SPIRIVA® HANDIHALER in Subjects w/COPD*

Clinical Trial Summary

This study is to characterize the pharmacodynamic characteristics and to assess the therapeutic bioequivalence after single dose of Tiotropium Bromide Inhalation Powder-test relative to Tiotropium Bromide Inhalation Powder-reference in Adult Patients with Chronic Obstructive Pulmonary Disease (COPD) as primary objective

Clinical Trial Description

Pharmadynamic study conducted in accordance requirements and recommendations per the US FDA's 2017 product specific "Draft Guidance on Tiotropium Bromide" ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05161156
Study type Interventional
Source Phargentis SA
Contact
Status Completed
Phase Phase 3
Start date March 24, 2022
Completion date November 29, 2022
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