Trials / Completed
CompletedNCT02627625
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Two Reference Products
Phase I Randomised, Five-period Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Three Test Products With Two Reference Products
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (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 three different inhalation products with the reference products in healthy volunteers.
Detailed description
Healthy subjects will be enrolled and will receive single doses of 3 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 8 hours post-dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tiotropium | 4 inhalations |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2016-03-01
- Completion
- 2016-06-01
- First posted
- 2015-12-11
- Last updated
- 2024-12-02
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02627625. Inclusion in this directory is not an endorsement.