Table 3.
Comparison of plasma Cmax and AUCτ for Japanese versus non-Japanese subjects following multiple dosing of AZD5718 at Day 10
Parameter | Dose (mg) | Japanese geometric mean | Non-Japanese geometric mean | GMR, % (90% CI) | Body weight normalized to 70 kg | ||
---|---|---|---|---|---|---|---|
Japanese geometric mean | Non-Japanese geometric mean | GMR, % (90% CI) | |||||
Cmax (nmol/L) | 60 | 158.9 | 219.8 | 72 (54–97) | 147.2 | 232.3 | 63 (48–84) |
AUCτ (nmol∙h/L) | 60 | 1140.5 | 1386.3 | 82 (63–108) | 1056.0 | 1464.7 | 72 (55–95) |
Cmax (nmol/L) | 180 | 1567.9 | 1243.2 | 126 (82–195) | 1374.9 | 1415.0 | 97 (65–145) |
AUCτ (nmol∙h/L) | 180 | 6724.5 | 5128.4 | 131 (88–196) | 5896.7 | 5837.1 | 101 (71–144) |
Cmax (nmol/L) | 360 | 3461.5 | 3209.2 | 108 (72–162) | 3272.4 | 3682.6 | 89 (60–131) |
AUCτ (nmol∙h/L) | 360 | 15,847.3 | 12,764.7 | 124 (83–186) | 14,981.4 | 14,647.6 | 102 (70–149) |
Cmax (nmol/L) | 600 | 6145.6 | 5692.8 | 108 (66–178) | 5818.4 | 6130.5 | 95 (64–142) |
AUCτ (nmol∙h/L) | 600 | 27,349.3 | 23,175.0 | 118 (73–190) | 25,893.0 | 24,956.5 | 104 (69–156) |
AUCτ area under the concentration–time curve over the dosing interval, Cmax peak plasma concentration, GMR geometric mean ratio, CI confidence interval