Trials / Completed
CompletedNCT04856098
Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler
A Pharmacokinetic Feasibility Study on Ultibro Breezhaler, an Indacaterol-glycopyrronium Inhalation Powder Capsule, in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Orion Corporation, Orion Pharma · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study is to assess pharmacokinetics (PK) of indacaterol and glycopyrronium, and methodology and practical arrangements for future studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Indacaterol maleate and glycopyrronium bromide | Batch A Ultibro Breezhaler 85/43 μg 2 capsules |
| DRUG | Indacaterol maleate and glycopyrronium bromide | Batch A Ultibro Breezhaler 85/43 μg 1 capsule |
| DRUG | Indacaterol maleate and glycopyrronium bromide | Batch B Ultibro Breezhaler 85/43 μg 2 capsules |
| DRUG | Ultibro Breezhaler with oral charcoal | Activated charcoal suspension, granules 50 g / bottle |
Timeline
- Start date
- 2021-05-07
- Primary completion
- 2021-09-21
- Completion
- 2021-09-21
- First posted
- 2021-04-22
- Last updated
- 2021-09-28
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT04856098. Inclusion in this directory is not an endorsement.