The fasting group | The fed group | |||
---|---|---|---|---|
Parameter (unit) | Mean ± SD(%CV) (N) | Mean ± SD(%CV) (N) | ||
Reference product | Test product | Reference product | Test product | |
*Tmax (h) | 5.00(3.00,8.00) (39) | 5.00 (3.00,6.00) (39) | 6.00(3.50,8.01) (39) | 5.00(3.50,8.01) (38) |
Cmax (ng/mL) | 257.949 ± 53.7058(20.82) (39) | 247.692 ± 63.4131(25.60) (39) | 204.641 ± 45.5264(22.25) (39) | 194.132 ± 47.4166(24.42) (38) |
AUC0-t(h*ng/mL) | 3159.4605 ± 537.1612 (17.00) (39) | 3039.8997 ± 554.6876(18.25) (39) | 2807.6025 ± 564.1152(20.09) (39) | 2743.1544 ± 565.2824(20.61) (38) |
AUC0-∞(h*ng/mL) | 3229.8289 ± 543.0014 (16.81) (39) | 3106.7115 ± 551.9343(17.77) (39) (18.25) (39) | 2897.0655 ± 587.1272(20.27) (39) | 2849.5667 ± 607.9339(21.33) (38) |
%AUCex (%) | 2.22 ± 0.72(32.52) (39) | 2.23 ± 0.96(43.23) (39) | 3.04 ± 2.15(70.62) (39) | 3.63 ± 1.82(50.04) (38) |
λz(1/h) | 0.1010 ± 0.0163(16.18) (39) | 0.1032 ± 0.0146(14.18) (39) | 0.0930 ± 0.0198(21.26) (39) | 0.0878 ± 0.0191(21.70) (38) |
t1/2 (h) | 7.05 ± 1.18(16.70) (39) | 6.85 ± 0.98(14.32) (39) | 7.88 ± 2.21(28.04) (39) | 8.28 ± 1.91(23.09) (38) |