Table 5a. Plasma PK comparisons from study 1 (CTT116415).
| Component measured |
Parameter | Treatment comparison | Treatment ratio (SE Loge) [90% CI for ratio] |
|---|---|---|---|
| FF | AUC(0–8) (h×pg/mL) | FF/UMEC/VI vs. FF/UMEC | 1.05 (0.029) [1.00 – 1.10] |
| FF/UMEC/VI vs. FF/VI | 1.17 (0.029) [1.12 – 1.23] | ||
| Cmax (pg/mL) | FF/UMEC/VI vs. FF/UMEC | 1.01 (0.045) [0.94 – 1.09] | |
| FF/UMEC/VI vs. FF/VI | 1.23 (0.045) [1.14 – 1.33] | ||
| UMEC | AUC(0–4) (h×pg/mL) | FF/UMEC/VI vs. FF/UMEC | 0.99 (0.032) [0.94 – 1.04] |
| FF/UMEC/VI vs. UMEC/VI | 0.98 (0.032) [0.93 – 1.04] | ||
| Cmax (pg/mL) | FF/UMEC/VI vs. FF/UMEC | 1.09 (0.075) [0.97 – 1.24] | |
| FF/UMEC/VI vs. FUMEC/VI | 0.99 (0.075) [0.87 – 1.12] | ||
| VI | AUC(0–2) (h×pg/mL) | FF/UMEC/VI vs. FF/VI | 1.20 (0.023) [1.15 – 1.24] |
| FF/UMEC/VI vs. UMEC/VI | 1.18 (0.023) [1.13 – 1.22] | ||
| Cmax (pg/mL) | FF/UMEC/VI vs. FF/VI | 1.46 (0.037) [1.38 – 1.56] | |
| FF/UMEC/VI vs. UMEC/VI | 1.33 (0.037) [1.25 – 1.42] |
SE = standard error.