Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-04 @ 12:21 PM
Study NCT ID:
NCT03155204
Status:
COMPLETED
Last Update Posted:
2024-12-02
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product
Sponsor:
Solventum US LLC
Organization:
Study Overview
Official Title:
Phase I Randomised, Five-period Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Four Test pMDI Products With Spiriva Respimat
Status:
COMPLETED
Status Verified Date:
2024-11
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:
The purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.
Detailed Description:
Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products and one reference inhalation product according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: