Table 2 Statistical results of pharmacokinetic parameters of oseltamivir
Fasting group | Fed group | |||
|---|---|---|---|---|
Parameter (unit) | Mean ± SD(%CV) (N) | Mean ± SD(%CV) (N) | ||
Reference product | Test product | Reference product | Test product | |
*Tmax (h) | 1.50(0.25,3.50) (39) | 1.25(0.25,3.00) (39) | 1.25(0.25,4.00) (39) | 1.25(0.25,4.00) (39) |
Cmax (ng/mL) | 49.4051 ± 16.9687(34.35) (39) | 48.7872 ± 17.7706(36.42) (39) | 43.8615 ± 14.8930(33.95) (39) | 44.1590 ± 16.9627(38.41) (39) |
AUC0-t(h*ng/mL) | 151.8912 ± 31.3853(20.66) (39) | 147.8547 ± 33.8070(22.87) (39) | 164.6864 ± 37.1978(22.59) (39) | 160.5601 ± 34.3109(21.37) (38) |
AUC0-∞(h*ng/mL) | 156.0173 ± 32.0316(20.53) (39) | 152.2639 ± 34.8439(22.88) (39) | 172.0658 ± 39.0278(22.68) (39) | 169.8901 ± 35.6103(20.96) (38) |
%AUCex(%) | 2.66 ± 1.72(64.89) (39) | 2.89 ± 1.53(52.88) (39) | 4.16 ± 3.02(72.68) (39) | 5.41 ± 5.08(93.96) (38) |
λz(1/h) | 0.2716 ± 0.1287(47.38) (39) | 0.2436 ± 0.1115(45.76) (39) | 0.1884 ± 0.1219(64.72) (39) | 0.1735 ± 0.1158(66.74) (38) |
t1/2 (h) | 3.34 ± 2.20(65.81) (39) | 3.67 ± 2.15(58.52) (39) | 6.18 ± 5.22(84.47) (39) | 7.23 ± 6.41(88.69) (38) |
CL/F(L/h) | 502.6043 ± 113.2300(22.53) (39) | 517.4635 ± 115.6803(22.36) (39) | 456.4798 ± 97.2214(21.30) (39) | 458.7121 ± 87.8661(19.15) (38) |
Vd/F(L) | 2340.3764 ± 1432.7326(61.22) (39) | 2628.4024 ± 1328.3567(50.54) (39) | 3804.2724 ± 2984.5745(78.45) (39) | 4627.3801 ± 4130.8730(89.27) (38) |