A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol

Summary

The study will evaluate bioavailability, pharmacokinetics, safety, and tolerability of budesonide, glycopyrronium and formoterol (BGF) metered dose inhaler (MDI) formulated with 3 different propellants: Propellant 1 (Treatment A \[test\]), Propellant 2 (Treatment B \[test\]) and Hydrofluoroalkane (HFA) (Treatment C \[reference\]).

Timeline

Start

2020-10-19

Primary completion

2021-05-17

Completion

2021-05-17

Publications

• Aurivillius M, Bednarczyk A, Kokot M, Madriaga J, Mei J, Collison K, Surujbally R, Archbell J, Joshi V, Gillen M. Relative bioavailability of budesonide/glycopyrrolate/formoterol fumarate triple therapy delivered using next generation propellants with low global warming potential. Pulm Pharmacol Ther. 2023 Dec;83:102245. doi: 10.1016/j.pupt.2023.102245. Epub 2023 Aug 20.

Drugs

Indications