The pharmacokinetics of three doses of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler compared with active controls: A Phase I randomized, single-dose, crossover study in healthy adults

Article ID	Journal	Published Year	Pages	File Type
8537711	Pulmonary Pharmacology & Therapeutics	2018	33 Pages	PDF

Abstract

In conclusion, BGF MDI 320/14.4/10 Î¼g had a similar budesonide PK profile to BUD/FORM MDI 320/9 Î¼g. No PK drug-drug interactions were observed when budesonide was added to glycopyrronium and formoterol fumarate dihydrate. These data support the use of budesonide 320 Î¼g and 160 Î¼g in future clinical trials of BGF MDI in COPD.

Keywords

Cmax LLQ BGF Formoterol fumarate dihydrate AUC0–∞AUC0–t GMR MDI AUC0–12 tmax ICS GFF LAMA TEAE long-acting muscarinic antagonist Long-acting β2-agonist ECG electrocardiogram standard deviation blq Budesonide Chronic obstructive pulmonary disease COPD lower limit of quantification maximum plasma concentration Metered Dose Inhaler time to maximum plasma concentration LSM LABA body mass index BMI adverse event treatment-emergent adverse event pharmacokinetic confidence interval Co-suspension delivery technology Least squares mean geometric mean ratio Inhaled corticosteroid Glycopyrronium