Table 4a. VI plasma PK summary in study 1 (CTT116415).
| Parameter | Treatmenta | N | n | Geometric mean (95% CI) |
%CVb |
|---|---|---|---|---|---|
| AUC(0–2) (h×pg/mL) | FF/UMEC/VI | 43 | 43 | 307 (289 – 327) | 19.9 |
| FF/VI | 42 | 42 | 260 (247 – 274) | 17.1 | |
| UMEC/VI | 41 | 41 | 264 (247 – 282) | 20.9 | |
| AUC(0–t) (h×pg/mL) | FF/UMEC/VI | 43 | 43 | 522 (482 – 565) | 26.4 |
| FF/VI | 42 | 42 | 462 (424 – 504) | 28.5 | |
| UMEC/VI | 41 | 41 | 439 (401 – 481) | 29.4 | |
| Cmax (pg/mL) | FF/UMEC/VI | 43 | 43 | 639 (586 – 696) | 28.6 |
| FF/VI | 42 | 42 | 442 (412 – 474) | 22.8 | |
| UMEC/VI | 41 | 41 | 486 (445 – 514) (445 – 532) | 28.8 | |
| t1/2 (h)b | FF/UMEC/VI | 43 | 39 | 8.6 (7.4, 10.0) (7.4 – 10.0) | 49.7 |
| FF/VI | 42 | 38 | 9.0 (7.4, 10.9) (7.4 – 10.9) | 63.8 | |
| UMEC/VI | 41 | 38 | 7.6 (6.4, 9.0) (6.4 – 9.0) | 53.9 | |
| tmax (h)b | FF/UMEC/VI | 43 | 43 | 0.1 (0.1, 0.2) (0.1, 0.3) | NA |
| FF/VI | 42 | 42 | 0.1 (0.1, 0.3) | NA | |
| UMEC/VI | 41 | 41 | 0.1 (0.1, 0.3) | NA | |
| tlast (h)b | FF/UMEC/VI | 43 | 43 | 12.0 12.1 (4.0, 24.1) | NA |
| FF/VI | 42 | 42 | 12.0 (4.0, 24.2) | NA | |
| UMEC/VI | 41 | 41 | 12.0 (2.0, 24.0) | NA |
aTotal dose as 4 consecutive doses: 400 μg FF, 500 μg UMEC, and 100 μg VI. bMedian (min, max).