Winnonlin version 7

Pharmacokinetic parameters were calculated by Phoenix WinNonlin Version 7.0 (Certara, L.P.). The plasma concentration data were analyzed using the non-compartmental analysis to obtain primary pharmacokinetic parameters such as t_1/2, AUC, C_max, T_max, the apparent oral clearance (CL/F), and the apparent volume of distribution (V_d/F). All experimental results were presented as the mean ± standard deviation (SD). Statistical comparisons were analyzed by independent-samples t-test procedure and one-way analysis of variance (ANOVA) using IBM SPSS Statistics 25 software. It was considered to be statistically significant when the p-value was less than 0.05.

According to the National Medical Products Administration (NMPA), for pharmacokinetics studies a sample size of 8–12 subjects is sufficient for an evaluation of pharmacokinetic characteristics. Thus, in the current study eight subjects were assigned in each cohort. All statistical tests were performed using SAS 9.4 software. Continuous variables were described as the mean (standard deviation) or median (minimum, maximum). Counting and grading data are shown as n (%). Pharmacokinetic parameters were calculated using non-compartmental analysis techniques with WinNonLin, version 7.0 (Certara, Princeton, NJ, United States). Results are presented as mean (SD). Time-to-peak (T_max) is shown as median (range). One-way analysis of variance (ANOVA) and Least Significance Difference (LSD) was used for comparison between groups.
A power model was used to explore the dose proportionality of a single dose of HSK3486 among elderly subjects. The pharmacokinetic-pharmacodynamic association was investigated by linear regression.