| Parameter |
FF |
CV (%) |
VI |
CV (%) |
| AUC(0–t’) (pg•h/mL) (geometric mean [95% CI]) |
| FF/VI 200/100 μg |
163.0 (122.7, 216.6) |
76 |
393.6 (343.5, 451.0) |
29 |
| FF/VI 400/100 μg |
292.8 (227.1, 377.4) |
66 |
403.7 (357.6, 455.7) |
25 |
| FF/VI 800/100 μg |
575.8 (436.2, 760.2) |
74 |
410.0 (363.6, 462.3) |
27 |
| Cmax (pg/mL) (geometric mean [95% CI]) |
| FF/VI 200/100 μg |
53.6 (46.6, 61.7) |
34 |
516.6 (450.8, 592.1) |
28 |
| FF/VI 400/100 μg |
64.8 (57.2, 73.4) |
30 |
564.9 (512.8, 622.2) |
22 |
| FF/VI 800/100 μg |
105.0 (92.2, 119.5) |
31 |
557.7 (501.0, 620.8) |
23 |
| tmax (h) (median [range]) |
| FF/VI 200/100 μg |
0.08 (0.08-1.50) |
NA |
0.115 (0.08-0.23) |
NA |
| FF/VI 400/100 μg |
0.17 (0.08-2.00) |
NA |
0.100 (0.08-0.18) |
NA |
| FF/VI 800/100 μg |
1.00 (0.08-4.00) |
NA |
0.150 (0.08-0.17) |
NA |
| t’ (h) (median [range]) |
| FF/VI 200/100 μg |
8.00 (3.00-32.00) |
NA |
10.00 (3.00-12.00) |
NA |
| FF/VI 400/100 μg |
8.00 (3.00-32.00) |
NA |
10.00 (3.00-12.00) |
NA |
| FF/VI 800/100 μg |
8.00 (3.00-32.00) |
NA |
10.00 (3.00-12.00) |
NA |
AUC(0-t’) = area under the curve from zero (pre-dose) to the time of last common measurable time point within subject; CI = confidence interval; Cmax = maximum plasma concentration; CV = coefficient of variation; FF=fluticasone furoate; NA = not applicable; t’ = time of last common measurable time point within a subject; tmax = time to maximum observed concentration; VI = vilanterol. |
