Trials / Completed
CompletedNCT03155204
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product
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
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 46 (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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tiotropium pMDI | inhalation |
Timeline
- Start date
- 2017-04-25
- Primary completion
- 2018-01-21
- Completion
- 2018-03-19
- First posted
- 2017-05-16
- Last updated
- 2024-12-02
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03155204. Inclusion in this directory is not an endorsement.