Table 3.
Treatment | Parameter | Japanese | Non-Asian | GMR, % (95% CI) | Bodyweight normalized to 70 kg
|
||
---|---|---|---|---|---|---|---|
Japanese | Non-Asian | GMR, % (95% CI) | |||||
Single dose, fasted | Cmax, ng/mL | 21.9 | 11.0 | 199 (167–237) | 20.6 | 13.1 | 157 (132–187) |
AUC0–24, ng·h/mL | 93.4 | 69.9 | 134 (111–161) | 87.9 | 83.3 | 106 (84.5–132) | |
Single dose, fed | Cmax, ng/mL | 21.9 | 15.4 | 142 (107–189) | 20.6 | 18.3 | 112 (88.5–143) |
AUC0–24, ng·h/mL | 195 | 111 | 176 (137–227) | 183 | 132 | 139 (114–170) | |
Multiple dose, fed | Cmax, ng/mL | 24.9 | 18.0 | 138 (112–171) | 23.4 | 21.5 | 109 (94.4–126) |
AUC0–24, ng·h/mL | 173 | 141 | 123 (93.0–162) | 163 | 168 | 96.9 (77.4–121) |
Notes: Data are geometric least square means. GMR, Japanese/non-Asian.
Abbreviations: Cmax, maximum plasma concentration; AUC0–24, area under verinurad concentration–time curve from 0 to 24 hours; GMR, geometric mean ratio; PK, pharmacokinetics.