Table 3.
Summary of fluticasone furoate pharmacokinetic parameters following inhaled fluticasone furoate 800 μg repeat dose and statistical analysis results
| Parameter (units) | Caucasian subjects n = 19 | Chinese subjects n = 20 | Japanese subjects n = 20 | Korean subjects n = 20 | Statistical comparison | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| n | Geometric mean (95% CI) | n | Geometric mean (95% CI) | n | Geometric mean (95% CI) | n | Geometric mean (95% CI) | Ethnic group comparison | Ratio of adjusted geometric mean | 90% CI of ratio | |
| Cmax (pg ml−1) | 18 | 118(99.6, 141) |
20 | 181(146, 225) |
20 | 164(144, 186) |
20 | 206(181, 234) |
Chinese : Caucasian | 1.542 | (1.282, 1.854) |
| Japanese : Caucasian | 1.404 | (1.167, 1.689) | |||||||||
| Korean : Caucasian | 1.755 | (1.459, 2.111) | |||||||||
| tmax (h)* | 18 | 0.63(0.25–2.00) |
20 | 0.75(0.25–4.00) |
20 | 0.50(0.00–1.00) |
20 | 0.50(0.25–1.50) |
Chinese : Caucasian | NC | NC |
| Japanese : Caucasian | |||||||||||
| Korean : Caucasian | |||||||||||
| AUC(0,24 h) (pg ml−1 h) | 18 | 1203(947, 1528) |
20 | 1989(1630, 2428) |
20 | 1817(1546, 2136) |
20 | 2093(1841, 2380) |
Chinese : Caucasian | 1.658 | (1.365, 2.013) |
| Japanese : Caucasian | 1.520 | (1.250, 1.848) | |||||||||
| Korean : Caucasian | 1.747 | (1.438, 2.123) | |||||||||
| t1/2 (h) | 15 | 25.5(22.6, 28.8) |
19 | 32.5(30.7, 34.5) |
19 | 30.6(27.6, 33.9) |
20 | 27.0(25.2, 28.9) |
Chinese : Caucasian | 1.283 | (1.040, 1.583) |
| Japanese : Caucasian | 1.255 | (1.017, 1.549) | |||||||||
| Korean : Caucasian | 1.120 | (0.909, 1.379) | |||||||||
*
Median (range). AUC(0,∞), area under the concentration-time curve from time zero extrapolated to infinity; CI, confidence interval; CL, total plasma clearance; Cmax, maximum concentration; n, number of subjects for whom pharmacokinetic parameter was derived; NC, statistical comparison not conducted; t1/2, terminal elimination half-life; tmax, time to maximum concentration.