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Table 3 Statistical results of pharmacokinetic parameters of oseltamivir carboxylate

From: Oseltamivir phosphate for suspension is bioequivalent to TAMIFLU in healthy volunteers: a randomized, open-label clinical study

 

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)

  1. Tmax Time to reach maximum concentration, CV(%) Coefficient of variation, Intraindividual variation, Cmax Maximum plasma concentration, AUC0-t Area under the plasma concentration–time curve from time 0 to last time Concentration, AUC0-∞ Area under the plasma concentration–time curve from time zero extrapolated to infinite time, %AUCex Percentage of AUC0-∞ obtained by extrapolation, λz Elimination rate constant, t1/2 Elimination halflife, Data are Mean ± SD, except *Tmax represent the median (minimum–maximum)
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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