2.4 Statistical analysis
This study enrolled 18 subjects whose sample size were not calculated by statistical power considerations. Based on the analysis set of PK and non-atrioventricular model (NCA) to calculate the PK parameters, including AUC0-t, AUC0-∞, Cmax, CL/F, Tmax, t1/2and Vz/F.
Concentrations of SHR2554 will be descriptively summarized The average and median plasma concentration-time curves were plotted according to the scheduled blood collection time. In addition, the actual blood sample collection time was used to plot the blood concentration-time curve of individual subjects. PK parameters of AUC0-t, AUC0-∞, Cmax, CL/F, t1/2and Vz/F were summarized by using case number, arithmetic mean, arithmetic standard deviation, median, minimum, maximum, geometric mean, geometric standard deviation, coefficient of variation and coefficient of geometric variation
Through natural logarithm transformation, The plasma SHR2554 PK parameters AUC0-∞ (if applicable), AUC0-t, and Cmax were estimated by fitting the mixed-effect models to determine the difference between the least-squares means and 90% confidence interval (CI) of SHR2554 combination and monotherapy. In the mixed-effect model, the drugs were considered fixed effects and the subjects were considered random effects. After model fitting, the least-squares mean difference and its 90% confidence interval were converted into the geometric mean ratio (combination/SHR2554 monotherapy) and the 90% confidence interval.
The adverse events, physical examination, vital signs, laboratory results, normal/abnormal changes were recorded during the trial to evaluate the relationship between abnormal changes and the tested drug.