Trials / Completed
CompletedNCT03302065
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Reference
Phase I Randomised, Four-period Balanced Incomplete Block Design Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Four Test pMDI Products With One Reference Product
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (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 two reference inhalation products according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 48 hours post-dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tiotropium |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2016-09-01
- Completion
- 2017-01-01
- First posted
- 2017-10-04
- Last updated
- 2024-12-02
Source: ClinicalTrials.gov record NCT03302065. Inclusion in this directory is not an endorsement.