Table 2.

Statistical comparison of the least squares (LS) geometric mean pharmacokinetic parameters following single and multiple oral doses of duloxetine in the Japanese and Caucasian racial groups

Parameter	Dose (mg)	LS geometric mean Japanese (90% CI)	LS geometric mean Caucasian (90% CI)	Ratio of geometric mean (J/C) (90% CI)	P-value for difference in geometric mean
Single-dose study
Cmax (ng ml−1)	20	14.7 (12.8, 17.0)	12.5 (10.8, 14.4)
	40	30.0 (26.2, 34.5)	25.5 (22.2, 29.3)
	60	45.6 (39.6, 52.5)	38.7 (33.6, 44.6)	1.18 (0.97, 1.43)	0.164
AUC (ng ml−1 h)	20	207 (172, 248)	169 (141, 203)
	40	452 (377, 541)	370 (308, 443)
	60	714 (595, 857)	584 (486, 702)	1.22 (0.95, 1.58)	0.194
t1/2 (h)	20	10.5 (9.72, 11.2)	9.67 (8.98, 10.4)
	40	10.8 (10.0, 11.5)	9.95 (9.27, 10.7)
	60	10.9 (10.2, 11.8)	10.1 (9.41, 10.9)	1.08 (0.98, 1.19)	0.195
Vz/F (l)	20	1459 (1261, 1689)	1648 (1423, 1909)
	40	1374 (1192, 1583)	1551 (1346, 1789)
	60	1326 (1148, 1532)	1497 (1295, 1731)	0.89 (0.72, 1.08)	0.314
Cmax,norm (ng ml−1)/(mg kg−1)	20	43.0 (37.6, 49.1)	43.8 (38.3, 50.1)
	40	43.7 (38.5, 49.7)	44.6 (39.2, 50.7)
	60	44.2 (38.7, 50.4)	45.0 (39.5, 51.4)	0.98 (0.82, 1.18)	0.861
AUCnorm (ng ml−1 h)/(mg kg−1)	20	601 (508, 710)	591 (499, 699)
	40	657 (557, 774)	646 (548, 762)
	60	692 (586, 817)	681 (576, 804)	1.02 (0.81, 1.28)	0.907
Multiple-dose study
Vss/F (l)	20	1548 (1156, 2073)	1784 (1332, 2389)	0.87 (0.57, 1.31)	0.564
	40	1175 (877, 1573)	1681 (1256, 2252)	0.70 (0.46, 1.06)	0.151
Cmax,ss,norm (ng ml−1)/(mg kg−1)	20	81.4 (59.3, 112)	72.2 (52.6, 99.1)	1.13 (0.72, 1.76)	0.654
	40	108 (78.4, 148)	80.7 (58.8, 111)	1.33 (0.85, 2.08)	0.284
AUCτ,ss,norm (ng ml−1 h)/(mg kg−1)	20	668 (481, 927)	604 (435, 840)	1.10 (0.69, 1.76)	0.718
	40	966 (695, 1341)	693 (499, 963)	1.39 (0.88, 2.22)	0.235