Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT05161156
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2021-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Tiotropium Bromide Inhalation Powder
Sponsor:
Phargentis SA
Organization:
Study Overview
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*
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Pharmadynamic study conducted in accordance requirements and recommendations per the US FDA's 2017 product specific "Draft Guidance on Tiotropium Bromide"
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: