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.