Safety and Tolerability
Data from 108 subjects were included in this safety evaluation. Of the
36 subjects enrolled in the fasting group, all completed the two cycle
study. Of these, 10 subjects (27.8% of 36) reported 17 drug-related
AEs. Of the 17 AEs, 6 subjects (16.7% of 36) experienced 6 post-dose
AEs related to the test product and 6 subjects (16.7% of 36)
experienced 11 post-dose AEs related to the reference product. In terms
of the severity of AEs, all AEs were classified as level 1 to level 2
(NCI CTCAE 4.03) , and there were no AEs of level 3 or above. No severe
AEs (SAE) occurred during the treatment.
In the postprandialgroup, 72 subjects were recruited and 71 subjects
completed both periods of the study. A total of 19 subjects (26.4% of
72) reported 37 drug-related AEs. 10 subjects (13.9% of 72) experienced
14 post-dose AEs related to the test product and 10 subjects (13.9% of
72) experienced 23 post-dose AEs related to the reference product. Among
these AES, there were two events of hypertension, severity level 3,
related to T and R tablet administrations respectively . In this group,
one subject withdrew due to tachycardia. No SAEs or deaths were observed
during the study.
During the last scheduled visit, all AEs were resolved in both groups.