Safety and tolerability evaluations
ADVERSE EVENT, ADVERSE EVENT
The tolerability and safety of ezetimibe tablet were evaluated based on adverse-event reports, physical examinations, vital signs (body temperature, blood pressure and heart rate), 12-lead ECG and clinical laboratory tests (serum chemistry, hematology and urinalysis). Vital signs, were measured in each stage (screening, pre-administration and at 1, 4, 12, 24, 48, 72 h after administration). Routine laboratory tests and 12-lead ECG were conducted at screening and before removal from the study (18 days). Adverse events (AEs) were monitored throughout the study and were graded in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.