Parameter FF
Geometric Mean		   CV (%) VI
Geometric Mean		   CV (%)
AUC(0-t) (pg•h/mL)
Inhaled FF/VI 1676 (1362, 2062) 41 227 (180, 287) 46
Intravenous FF or VI 3442 (3069, 3861) 22 457 (371, 564) 41
Cmax (pg/mL)
Inhaled FF/VI 108 (93.2, 126) 29 298 (241, 367) 41
Intravenous FF or VI 5260 (4442, 6228) 33 490 (421, 570) 29
t½ (h)
Inhaled FF/VI 23.7 (20.8, 26.9) 23 2.47 (1.65, 3.70) 84
Intravenous FF or VI 15.4 (13.1, 18.2) 30 2.40 (1.65, 3.48) 76
tmax (h)a
Inhaled FF/VI 1.00 (0.08, 3.00) NA 0.17 (0.08, 0.25) NA
Intravenous FF or VI 0.33 (0.17, 0.33) NA 0.75 (0.50, 1.02) NA
CL (L/h)
Intravenous FF or VI 65.4 (58.8, 72.8) 20 108 (86.2, 135) 42
Vss (L)
Intravenous FF or VI 661 (546, 800) 36 165 (129, 211) 46
F (%)
Inhaled FF/VI 15 (13, 18) NA 27 (22, 35) NA
aMedian and range presented.
bResults from statistical analysis; ratio of geometric mean and 90% CI presented.
AUC = area under the curve; CI = confidence interval; CL = clearance; Cmax = maximum observed concentration; CV = coefficient of variation; F = absolute bioavailability; FF = fluticasone furoate; NA = not applicable; t½ = terminal elimination half-life; tmax = time to maximum observed concentration; VI = vilanterol; Vss = volume of distribution at steady state.
Table 3: Pharmacokinetic parameters of FF and VI following inhaled administration of FF/VI (800/100 μg) and intravenous FF (250 μg) or VI (55 μg) (geometric mean 95% CI) and results of statistical analysis to estimate absolute bioavailability [absolute bioavailability Study 2].
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