Table 2.
Summary of fluticasone furoate pharmacokinetic parameters following FF 250 μg single dose i.v. administration 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 | 4224(3278, 5442) |
20 | 5431(4878, 6046) |
19 | 5231(4498, 6083) |
20 | 5972(5400, 6604) |
Chinese : Caucasian | 1.296 | (1.085, 1.548) |
| Japanese : Caucasian | 1.270 | (1.059, 1.522) | |||||||||
| Korean : Caucasian | 1.435 | (1.201, 1.714) | |||||||||
| tmax (h)* | 18 | 0.33(0.17–0.75) |
20 | 0.33(0.17–0.75) |
19 | 0.33(0.17–0.42) |
20 | 0.33(0.17–0.35) |
Chinese : Caucasian | NC | NC |
| Japanese : Caucasian | |||||||||||
| Korean : Caucasian | |||||||||||
| AUC(0,∞) (pg ml−1 h) | 17 | 3505(3206, 3832) | 19 | 4347(3855, 4901) | 18 | 3537(3067, 4079) | 19 | 4194(3915, 4493) | Chinese : Caucasian | 1.243 | (1.099, 1.407) |
| Japanese : Caucasian | 1.019 | (0.897, 1.157) | |||||||||
| Korean : Caucasian | 1.204 | (1.063, 1.364) | |||||||||
| t1/2 (h) | 17 | 13.7(10.7, 17.6) | 19 | 18.2(16.1, 20.6) | 18 | 14.7(11.9, 18.2) | 19 | 16.2(15.4, 17.2) | Chinese : Caucasian | 1.341 | (1.106, 1.625) |
| Japanese : Caucasian | 1.107 | (0.908, 1.349) | |||||||||
| Korean : Caucasian | 1.209 | (0.996, 1.467) | |||||||||
| CL (l h−1) | 17 | 71.3(65.2, 78.0) | 19 | 57.5(51.0, 64.9) | 18 | 70.7(61.3, 81.5) | 19 | 59.6(55.6, 63.9) | Chinese : Caucasian | 0.804 | (0.711, 0.910) |
| Japanese : Caucasian | 0.982 | (0.865, 1.115) | |||||||||
| Korean : Caucasian | 0.830 | (0.733, 0.940) | |||||||||
| Vss (l) | 17 | 607(473, 780) | 19 | 652(516, 823) | 18 | 681(510, 910) | 19 | 561(508, 620) | Chinese : Caucasian | 1.074 | (0.830, 1.389) |
| Japanese : Caucasian | 1.123 | (0.861, 1.464) | |||||||||
| Korean : Caucasian | 0.925 | (0.713, 1.199) | |||||||||
*
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; Vss, steady-state volume of distribution.