Table 2a. FF Plasma PK summary in study 1 (CTT116415).
| Parameter | Treatmenta | N | n | Geometric mean (95% CI) |
%CVb |
|---|---|---|---|---|---|
| AUC(0–8) (h×pg/mL) | FF/UMEC/VI | 43 | 43 | 383 (357 – 410) | 23.0 |
| FF/UMEC | 43 | 42 | 366 (333 – 402) | 30.6 | |
| FF/VI | 42 | 42 | 322 (298 – 348) | 25.5 | |
| AUC(0–t) (h×pg/mL) | FF/UMEC/VI | 43 | 43 | 882 (774 – 1,005) | 44.3 |
| FF/UMEC | 43 | 42 | 765 (653 – 897) | 54.4 | |
| FF/VI | 42 | 42 | 662 (570 – 768) | 50.7 | |
| Cmax (pg/mL) | FF/UMEC/VI | 43 | 43 | 79.4 (71.7 – 88.0) | 34.2 |
| FF/UMEC | 43 | 42 | 79.2 (71.0 – 88.3) | 36.2 | |
| FF/VI | 42 | 42 | 63.6 (58.0 – 69.6) | 29.9 | |
| t1/2 (h)b | FF/UMEC/VI | 43 | 29 | 21.6 (17.2, 27.1) (17.2 – 27.1) | 65.0 |
| FF/UMEC | 43 | 29 | 20.7 (16.7, 25.7) (16.7 – 25.7) | 62.2 | |
| FF/VI | 42 | 25 | 22.4 (17.6, 28.3) (17.6 – 28.3) | 62.5 | |
| tmax (h)b | FF/UMEC/VI | 43 | 43 | 0.2 (0.1, 2.0) | NA |
| FF/UMEC | 43 | 42 | 0.5 (0.1, 2.0) | NA | |
| FF/VI | 42 | 42 | 1.0 (0.1, 2.1) | NA | |
| tlast (h)b | FF/UMEC/VI | 43 | 43 | 36.0 (8.0, 48.2 48.3) | NA |
| FF/UMEC | 43 | 42 | 36.0 (8.0, 48.2) | NA | |
| FF/VI | 42 | 42 | 24.0 (8.0, 48.1) | NA |
aTotal dose as 4 consecutive doses: 400 μg FF, 500 μg UMEC, and 100 μg VI. bMedian (min, max). AUC = area under the plasma concentration-time curve; Cmax = maximum observed plasma concentration; CVb = between subject coefficient of variation; FF = fluticasone furoate; N = total number of subjects who received this study medication, n = number of subjects for whom parameter derived; NA = not applicable; PK = pharmacokinetics; t1/2 = terminal phase half-life; tlast = time of last measurable concentration; tmax = time to Cmax; UMEC = umeclidinium; VI = vilanterol.