Table 3a. UMEC plasma PK summary in study 1 (CTT116415).
| Parameter | Treatmenta | N | n | Geometric mean (95% CI) |
%CVb |
|---|---|---|---|---|---|
| AUC(0–4) (h×pg/mL) | FF/UMEC/VI | 43 | 43 | 494 (459 – 531) | 23.9 |
| FF/UMEC | 43 | 42 | 498 (461 – 537) | 24.9 | |
| UMEC/VI | 41 | 41 | 502 (463 – 544) | 26.1 | |
| AUC(0–t) (h×pg/mL) | FF/UMEC/VI | 43 | 43 | 885 (785 – 997) | 40.3 |
| FF/UMEC | 43 | 42 | 797 (712 – 893) | 37.6 | |
| UMEC/VI | 41 | 41 | 931 (810 – 1,070) | 46.2 | |
| Cmax (pg/mL) | FF/UMEC/VI | 43 | 43 | 1,189 (1,015 – 1,392) | 54.9 |
| FF/UMEC | 43 | 42 | 1,099 (950 – 1,271) | 49.2 | |
| UMEC/VI | 41 | 41 | 1,217 (1,016 – 1,459) | 62.4 | |
| t1/2 (h)b | FF/UMEC/VI | 43 | 12 | 24.6 (12.0, 50.4) | 161 |
| FF/UMEC | 43 | 19 | 14.3 (8.0, 25.4) | 179 | |
| UMEC/VI | 41 | 15 | 17.8 (8.5, 37.4) | 224 | |
| tmax (h)b | FF/UMEC/VI | 43 | 43 | 0.1 (0.1, 0.2) | NA |
| FF/UMEC | 43 | 42 | 0.1 (0.1, 0.2) | NA | |
| UMEC/VI | 41 | 41 | 0.1 (0.1, 0.3) | NA | |
| tlast (h)b | FF/UMEC/VI | 43 | 43 | 36.0 (8.0, 48.1) | NA |
| FF/UMEC | 43 | 42 | 24.0 (4.0, 48.2) | NA | |
| UMEC/VI | 41 | 41 | 36.0 (6.0, 48.3) | NA |
aTotal dose as 4 consecutive doses: 400 μg FF, 500 μg UMEC, and 100 μg VI. bMedian (min, max).