RESULTS
Among a total of 190 subjects who gave informed consent, 88 subjects
received the study drugs and 85 subjects completed the study (Figure 1).
There were no exclusions from the analysis, and all 88 subjects were
included in the PK analysis set and the safety analysis set. Baseline
demographics were generally similar across all treatment groups (Table
1). When carotegrast methyl was repeatedly administered for 14 days from
days 1 to 14, time course of the mean plasma concentration of oral
midazolam, oral prednisolone, oral atorvastatin, and intravenous
midazolam on days -1, 7, 14, 28, and 48 is shown in Figure 2. These PK
parameters and drug-drug interaction between carotegrast methyl and
CYP3A4 substrates are shown in Table 2 and Table 3, respectively.