Table 4 Summary of the exploratory analysis of plasma MF PK parameters (high dose [160Â ÎĽg] versus medium dose [80Â ÎĽg] on Day 1 and Day 14)
Ethnic group | PK parameter (unit) | Day 1 | Day 14 | ||||
|---|---|---|---|---|---|---|---|
Adjusted geometric mean | Adjusted geometric mean ratio (test/reference) | Adjusted geometric mean | Adjusted geometric mean ratio (test/reference) | ||||
IND/GLY/MF high-dose (test) | IND/GLY/MF medium-dose (reference) | Estimate (90% CI) | IND/GLY/MF high-dose (test) | IND/GLY/MF medium-dose (reference) | Estimate (90% CI) | ||
Japanese | Cmax (pg/mL) | 195 (n = 14) | 104 (n = 16) | 1.87 (1.73, 2.02) | 264 (n = 14) | 139 (n = 16) | 1.91 (1.79, 2.02) |
|  | AUC0–24 h (hxpg/mL) | 1700 (n = 14) | 926 (n = 16) | 1.84 (1.72, 1.97) | 2520 (n = 14) | 1260 (n = 16) | 2.00 (1.92, 2.09) |
Caucasian | Cmax (pg/mL) | 193 (n = 15) | 96.3 (n = 16) | 2.00 (1.86, 2.16) | 247 (n = 15) | 121 (n = 16) | 2.04 (1.93, 2.16) |
|  | AUC0–24 h (hxpg/mL) | 1600 (n = 15) | 784 (n = 16) | 2.03 (1.90, 2.17) | 2180 (n = 15) | 1030 (n = 16) | 2.13 (2.04, 2.21) |