Table 2.

Fluticasone Propionate and Salmeterol Pharmacokinetic Parameters by Study (Pharmacokinetic Parameter Set)

	Study 1		Study 2		Study 3
Treatmenta	FP/S 100/50 μg		FP/S 250/50 μg		FP/S 500/50 μg
Device	T (n = 65)	R (n = 65)	T (n = 65)	R (n = 64)	T (n = 65)	R (n = 66)
FP PK parameters
Tmax, h	0.75 (0.08–1.50)	0.75 (0.08–1.50)	1.00 (0.08–3.00)	1.00 (0.33–3.01)	1.50 (0.33–4.00)	1.50 (0.33–4.00)
Cmax, pg/mL	109.7 ± 36.2	118.6 ± 35.5	170.0 ± 53.7	173.6 ± 56.4	261.6 ± 69.1	290.9 ± 74.0
AUC(0-t), pg·h/mL	638 ± 201	609 ± 179	1298 ± 418	1237 ± 379	2851 ± 970	2919 ± 831
T1/2, h	10.18 ± 2.46b	9.95 ± 2.77d	11.24 ± 1.80e	10.38 ± 1.71f	12.23 ± 2.68c	10.57 ± 1.90
Salmeterol PK parameters
Tmax, h	0.08 (0.03–1.50)	0.08 (0.03–2.00)	0.08 (0.04–1.01)	0.08 (0.05–2.01)	0.08 (0.03–1.00)	0.08 (0.03–1.50)
Cmax, pg/mL	385.4 ± 162.8	379.3 ± 143.9	319.5 ± 137.8	352.8 ± 158.1	376.6 ± 181.3	418.0 ± 145.8
AUC(0-t), pg·h/mL	727 ± 223	677 ± 245	700 ± 340	686 ± 324	724 ± 297	708 ± 236
T1/2, h	11.87 ± 1.54c	12.21 ± 1.93	11.55 ± 1.71	11.66 ± 1.86e	11.21 ± 2.01	11.56 ± 1.86g

Data are shown as arithmetic mean ± standard deviation for all parameters except T_max, which is shown as median (range).

^aThree inhalations in each study, resulting in total FP/S doses of 300/150 μg (study 1), 750/150 μg (study 2), and 1500/150 μg (study 3).

^bn = 62.

^cn = 64.

^dn = 60.

^en = 63.

^fn = 59.

^gn = 65.

AUC_(0-t), area under the concentration-time curve from time = 0 to the last measurable concentration; C_max, maximum plasma concentration; FP, fluticasone propionate; FP/S, fluticasone propionate/salmeterol; h, hours; PK, pharmacokinetic; R, reference product (Advair^® Diskus^®); T, test product (Wixela^® Inhub^®); T_1/2, terminal elimination half-life; T_max, time to maximum plasma concentration.