drugset / Trial / NCT06723756
A Study to Investigate the Exposure of Budesonide, Glycopyrronium, and Formoterol (BGF) Delivered by Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) Compared to a Hydrofluoroalkane (HFA) Propellant MDI in Healthy Adults
RandomizedCrossoverDouble-blindTreatment
Summary
This study aims to assess the bioequivalence of the total systemic exposure and safety of budesonide, glycopyrronium, and formoterol (160/14.4/4.8 µg/actuation) when administered as BGF MDI HFO compared with BGF MDI HFA in healthy participants.
Timeline
- Start
- 2025-01-23
- Primary completion
- 2025-06-01
- Completion
- 2025-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 320 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 9.6 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 28.8 ug | Inhaled |
Indications
No indication recorded.