drugset / Trial / NCT06297668
A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-Generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer
RandomizedCrossoverQuadruple-blindTreatment
Summary
This study aims to assess the effect on total systemic exposure and to characterize exposure BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF MDI HFA with a spacer.
Timeline
- Start
- 2024-04-29
- Primary completion
- 2024-06-11
- Completion
- 2024-06-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Budesonide | Small molecule | 160 ug | Inhaled |
| Comparator | Formoterol | Other / unclassified | 4.8 ug | Inhaled |
| Comparator | Glycopyrronium | Unknown | 7.2 ug | Inhaled |