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.