Table 2.
Treatment | AUCτ mIU/mL*h) | Cmax, ss (mIU/mL) | tmax (h) | Ctrough (mIU/mL) | t1/2 (h) | |
HX575 | Mean | 8422 | 2189 | 0.086 | 9.811 | 4.14 |
SD | 2419 | 393.7 | 0.019 | 2.728 | 1.71 | |
Min | 4327 | 1203 | 0.083 | 5.565 | 1.90 | |
Median | 7930 | 2180 | 0.083 | 9.174 | 3.48 | |
Max | 19321 | 3197 | 0.200 | 18.61 | 8.43 | |
GeoM | 8153 | 2153 | - | 9.486 | 3.85 | |
GeoCV | 25.4% | 19.3% | - | 26.2% | 39.0% | |
Comparator | Mean | 9224 | 2262 | 0.083 | 9.446 | 4.74 |
SD | 1850 | 422.0 | 0.000 | 2.438 | 2.00 | |
Min | 4977 | 1272 | 0.083 | 5.020 | 1.31 | |
Median | 9181 | 2210 | 0.083 | 9.161 | 4.45 | |
Max | 13268 | 3161 | 0.083 | 15.77 | 11.03 | |
GeoM | 9036 | 2222 | - | 9.141 | 4.37 | |
GeoCV | 21.1% | 19.7% | - | 26.6% | 43.5% |
AUCτ = area under total concentration curve from 0–36 h at steady state; Cmax, ss = peak serum concentration at steady state; tmax = time to Cmax, ss; Ctrough = mean pre-dose trough concentration; t1/2 = terminal elimination half-life; SD = standard deviation; GeoM = geometric mean; GeoCV = coefficient of variation of GeoM. Number of subjects analysed: n = 37 (HX575) and n = 39 (comparator).