Table 4.
Summary of fluticasone furoate pharmacokinetic parameters following inhaled FF 200 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 | 41.1(32.8, 51.5) |
20 | 66.9(57.5, 77.9) |
20 | 55.7(46.6, 66.5) |
20 | 72.3(65.9, 79.3) |
Chinese : Caucasian | 1.637 | (1.361, 1.969) |
| Japanese : Caucasian | 1.373 | (1.141, 1.653) | |||||||||
| Korean : Caucasian | 1.776 | (1.477, 2.137) | |||||||||
| tmax(h)* | 18 | 0.50(0.25–3.00) |
20 | 0.50(0.25–4.00) |
20 | 0.50(0.25–4.00) |
20 | 0.50(0.25–2.00) |
Chinese : Caucasian | NC | NC |
| Japanese : Caucasian | |||||||||||
| Korean : Caucasian | |||||||||||
| AUC(0,tlast) (pg ml−1 h) | 18 | 222(135, 366) |
20 | 588(454, 761) |
20 | 430(317, 584) |
20 | 607(536, 686) |
Chinese : Caucasian | NC | NC |
| Japanese : Caucasian | |||||||||||
| Korean : Caucasian | |||||||||||
| AUC(0,24 h) (pg ml−1 h) | 9 | 541(440, 666) |
18 | 680(603, 767) |
16 | 561(454, 694) |
19 | 629(566, 698) |
Chinese : Caucasian | 1.487 | (1.190, 1.858) |
| Japanese : Caucasian | 1.274 | (1.015, 1.598) | |||||||||
| Korean : Caucasian | 1.439 | (1.153, 1.797) | |||||||||
*
Median (range). AUC(0,24 h), area under the concentration time curve from time zero to 24 h; AUC(0,tlast), area under the concentration–time curve from time zero to time of last quantifiable concentration; CI, confidence interval; Cmax, maximum concentration; n, number of subjects for whom pharmacokinetic parameter was derived; NC, statistical comparison not conducted; tmax, time to maximum concentration.