Safety
No serious AEs were reported, and no subject discontinued the study due to AEs. Twenty-four AEs in 10 subjects were considered to be related to the following investigational products: 1 AE (diarrhoea) in 1 subject after EVO, 5 AEs (blood bilirubin increased, hypoglycaemia, nausea, dizziness, and cold sweat) in 3 subjects after GLI and 18 AEs (abdominal discomfort, asthenia, blood bilirubin increased, cold sweat, dizziness, nausea, throat irritation, etc.) in 9 subjects after EVO+GLI (Table 4).
In clinical laboratory tests, no clinically significant changes were observed when compared to the baseline values, except for a case of total bilirubin increase. Furthermore, there were no clinically significant changes in physical examination, vital signs, and 12-lead electrocardiograms.