NCT02676297

Cross-over Study in Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Test and Reference Products

Phase I Randomised, Three-period Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Two Test Products With Spiriva Respimat Comparator Product

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the absorption of two different inhalation products with the reference product in healthy volunteers.

Detailed description

Healthy subjects will be enrolled and will receive single doses of 2 test inhalation products and one reference inhalation product according to a three-period cross-over design. Subjects will use the patient instruction leaflet to understand how each inhaler is administered. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	tiotropium	four inhalations

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-05-01
• Completion: 2016-07-01
• First posted: 2016-02-08
• Last updated: 2024-12-02

Locations

1 site across 1 country: United Kingdom