Subject characteristics
A total of 181 subjects were screened for inclusion; 92 healthy subjects
(40 fasting group and 52 fedgroup) were randomized into each of the
study group, and 75 subjects (39 of fasting group and 36 of fed group)
completed the study. 1 subject in fasting group withdrew because of
pregnancy before admission in second period. 12 subjects in fed group
fell off as a result of failing to finish the high-fat breakfast within
30 minutes, and replaced by the other subjects from the waiting list;
besides, another 4 subjects dropped out due to poor compliance,
voluntary withdrawal and AE of tonsillitis.
Data from the subjects who received a study drug at least once were used
for safety assessment and subjects who completed the study were included
in the PK analysis. The baseline demographic characteristics of subjects
showed no statistical difference between the sequence groups (Table2).