Table 2 Summary of PK parameters after single (Day 1) and multiple doses (Day 14) of IND/GLY/MF administered via oral inhalation in healthy subjects
| Â | Japanese | Caucasian | |||
|---|---|---|---|---|---|
PK parameters (unit) | Profile day | IND/GLY/MF medium-dose N = 15/16 | IND/GLY/MF high-dose N = 13/14 | IND/GLY/MF medium-dose N = 17 | IND/GLY/MF high-dose N = 15 |
Analyte: indacaterol | |||||
 Cmax (pg/mL) | Day 1 | 388 (25.3) | 338 (28.7) | 275 (31.8) | 282 (33.0) |
Day 14 | 595 (27.2) | 593 (27.9) | 460 (25.8) | 461 (21.1) | |
 AUC0–24 h (h×pg/mL) | Day 1 | 1090 (25.0) | 1010 (34.5) | 862 (25.8) | 897 (28.6) |
Day 14 | 3360 (30.3) | 3330 (37.1) | 2750 (23.0) | 2800 (20.3) | |
 Tmax (h) | Day 1 | 0.250 (0.250–0.500) | 0.250 (0.250–0.250) | 0.250 (0.250–0.250) | 0.250 (0.250–0.250) |
Day 14 | 0.250 (0.250–0.250) | 0.250 (0.250–0.250) | 0.250 (0.250–0.250) | 0.250 (0.250–0.250) | |
 Racc (AUC) | Day 14 | 3.09 (17.8) | 3.32 (24.2) | 3.31 (25.2) | 3.30 (27.8) |
 Racc (Cmax) | Day 14 | 1.57 (20.7) | 1.76 (22.1) | 1.75 (25.8) | 1.74 (27.1) |
Analyte: glycopyrronium | |||||
 Cmax (pg/mL) | Day 1 | 318 (53.5) | 296 (47.6) | 204 (46.2) | 215 (48.9) |
Day 14 | 467 (35.1) | 464 (42.7) | 300 (34.7) | 322 (28.9) | |
 AUC0–24 h (h×pg/mL) | Day 1 | 294 (25.3) | 278 (31.5) | 276 (35.2) | 280 (33.0) |
Day 14 | 772 (21.0) | 751 (17.5) | 734 (25.3) | 734 (20.7) | |
 Tmax (h) | Day 1 | 0.0833 (0.0833–0.0833) | 0.0833 (0.0833–0.0833) | 0.0833 (0.0833–0.0833) | 0.0833 (0.0833–0.0833) |
Day 14 | 0.0833 (0.0833–0.0833) | 0.0833 (0.0833–0.0833) | 0.0833 (0.0833–0.0833) | 0.0833 (0.0833–0.0833) | |
 Racc (AUC) | Day 14 | 2.74 (27.5) | 2.86 (25.4) | 2.84 (30.2) | 2.83 (28.4) |
 Racc (Cmax) | Day 14 | 1.69 (41.8) | 1.80 (46.3) | 1.68 (42.4) | 1.90 (65.2) |
Analyte: mometasone furoate | |||||
 Cmax (pg/mL) | Day 1 | 105 (16.3) | 197 (18.3) | 98.6 (22.3) | 195 (16.5) |
Day 14 | 141 (18.8) | 268 (18.9) | 123 (17.9) | 252 (14.8) | |
 AUC0–24 h (h×pg/mL) | Day 1 | 936 (15.0) | 1730 (16.8) | 800 (19.9) | 1620 (19.2) |
Day 14 | 1270 (15.8) | 2540 (14.0) | 1040 (16.2) | 2220 (12.6) | |
 Tmax (h) | Day 1 | 2.00 (0.500–3.00) | 1.00 (0.250–2.00) | 1.00 (0.250–2.00) | 2.00 (0.250–2.00) |
Day 14 | 2.00 (0.250–3.00) | 2.00 (0.250–3.00) | 1.00 (0.250–3.00) | 1.00 (0.250–2.00) | |
 Racc (AUC) | Day 14 | 1.37 (14.2) | 1.50 (20.1) | 1.33 (17.1) | 1.40 (12.8) |
 Racc (Cmax) | Day 14 | 1.35 (15.3) | 1.38 (18.6) | 1.28 (19.8) | 1.31 (17.5) |