This is a Phase I, randomized, double-blind, single-dose, single-center, partial-replicate, 3 way cross-over study to assess pharmacokinetic and safety of BGF MDI when administered with different propellants, HFO (HFO-1234ze) - test and HFA (HFA-134a) - reference.~The study will comprise of:~A screening period up to 28 days prior to first dosing;~Three Treatment Periods: Participants will be resident at the Clinical Unit from the morning on the day before dosing with BGF MDI on Day -1 of Treatment Period 1, until 24 hours following the final dose on Day 2 of Treatment Period 3, with a washout period of 3 to 7 days between each dose; and~Follow-up: final safety Follow-up Phone Call within 3 to 7 days after the last administration of BGF MDI in Treatment Period 3.~Each participant will receive 3 single dose treatments of BGF MDI (Treatment A: BGF MDI HFO [Test]; Treatment B: BGF MDI HFA [Reference]) following an overnight fast of at least 8 hours on Day 1 of each treatment period.~The reference formulation will be administered during 2 of the 3 treatment periods.~There will be a minimum of a 3 to 7 day washout between administration of each treatment.~Each participant will be involved in the study for approximately 55 days.
The study will evaluate bioequivalence, pharmacokinetics, safety, and tolerability of Budesonide, Glycopyrronium and Formoterol (BGF) metered dose inhaler (MDI) formulated with hydrofluoroolefin (HFO) [Test] and hydrofluoroalkane (HFA) [Reference] in healthy participants (male or female).