Table 2.

PK Parameters for Budesonide and Formoterol According to Treatment^a (PK Population)

Parameter	BGF MDI 320/14.4/10 μg	BFF MDI 320/10 μg	BUD/FORM DPI 320/9 μg
AUC0‐12, pg·h/mL
Budesonide	1762.47 (753.98), n = 64	1827.17 (738.71), n = 65	1516.86 (825.89), n = 65
Formoterol	42.86 (18.15), n = 60	42.34 (14.89), n = 62	26.73 (14.34), n = 58
AUC0‐t, pg·h/mL
Budesonide	1762.72 (754.16), n = 64	1826.72 (738.52), n = 65	1517.11 (826.15), n = 65
Formoterol	41.63 (19.46), n = 60	41.34 (15.63), n = 62	24.20 (16.05), n = 58
Cmax, pg/mL
Budesonide	528.91 (347.50), n = 64	505.48 (264.92), n = 65	595.11 (511.94), n = 65
Formoterol	9.36 (4.98), n = 60	8.34 (3.61), n = 62	8.39 (5.42), n = 58
tmax, hoursa
Budesonide	0.33 (0.10‐4.00), n = 64	0.67 (0.03‐4.00), n = 65	0.33 (0.03‐2.00), n = 65
Formoterol	0.67 (0.10‐12.00), n = 60	0.67 (0.10‐8.00), n = 62	0.10 (0.03‐2.00), n = 58
t½, hours
Budesonide	3.07 (0.42), n = 64	3.07 (0.64), n = 65	3.04 (0.47), n = 64
Formoterol	5.13 (2.23), n = 40	5.20 (2.51), n = 47	5.19 (1.78), n = 28
Cl/F, L/hour
Budesonide	207.34 (125.64), n = 64	203.54 (116.62), n = 64	361.83 (268.79), n = 64
Formoterol	204.77 (55.15), n = 17	184.83 (40.71), n = 21	251.90 (75.18), n = 10

AUC_0‐12, area under the plasma drug concentration‐time curve from 0‐12 hours; AUC_0‐t, area under the plasma drug concentration‐time curve up to the last measurable plasma concentration; BFF, budesonide/formoterol fumarate dihydrate; BGF, budesonide/glycopyrronium/formoterol fumarate dihydrate; BUD/FORM, budesonide/formoterol fumarate dihydrate; C_max, maximum observed plasma concentration; Cl/F, apparent total body clearance; DPI, dry powder inhaler; MDI, metered dose inhaler; PK, pharmacokinetic; SD, standard deviation; t_½, apparent terminal elimination half‐life; T_max, time to maximum observed plasma concentration.

^aAll pharmacokinetic values are expressed as the arithmetic mean (SD) with the exception of T_max, which is expressed as the median value (min‐max).