Table 4.
Summary of pharmacokinetic parameters following repeat dose co-administration of FF/VI with ketoconazole or placebo for 7 days (study 2)
| Parameter | Treatment | Fluticasone furoate | Vilanterol | ||
|---|---|---|---|---|---|
| Geometric mean (CV%) | 95% CI | Geometric mean (CV%) | 95% CI | ||
| AUC* (pg h ml−1) | FF/VI + placebo | 715 (24.2) | (635, 806) | 76.1 (124) | (47.1, 123) |
| FF/VI + ketoconazole | 970 (53.5) | (756, 1245) | 125 (186) | (68.1, 230) | |
| Cmax (pg ml−1) | FF/VI + placebo | 62 (14.6) | (57.7, 66.7) | 120 (59.6) | (91.5, 158) |
| FF/VI + ketoconazole | 82.5 (34.6) | (69.8, 97.5) | 147 (46.5) | (118, 183) | |
| t1/2 (h) | FF/VI + placebo | 22.0 (34.6) | (16.1, 30.1) | 1.11 (103) | (0.45, 2.70) |
| FF/VI + ketoconazole | 22.2 (15.3) | (19.9, 24.8) | 7.51 (72.2) | (4.56, 12.3) | |
| tmax† (h) | FF/VI + placebo | 0.77 (0.00–2.00) | NA | 0.08 (0.08–0.25) | NA |
| FF/VI + ketoconazole | 2.00 (0.00–4.02) | NA | 0.08 (0.00–0.25) | NA | |
| CL/F (l h−1) | FF/VI + placebo | 280 (24.2) | (248, 315) | 257 (82.4) | 178, 372 |
| FF/VI + ketoconazole | 206 (53.5) | (161, 265) | 80.9 (129) | 49.4, 132 | |
Abbreviations: AUC, area under the curve; CI, confidence interval; CL/F, apparent clearance; Cmax, maximum plasma concentration; CV, coefficient of variation; FF, fluticasone furoate; NA, not applicable; t1/2, half-life; tmax, time to maximum plasma concentration; VI, vilanterol trifenatate.
*
FF = AUC(0–24); VI = AUC(0–t′).
†
Median (range).