RESULTS
Among a total of 66 subjects who gave informed consent, 20 subjects were
randomly assigned to sequence A (n = 10) or sequence B (n = 10). All
subjects received the study drugs in period I and period II
(Figure 2). Baseline demographics
were generally similar across all treatment groups (Table 1).
There were no exclusions from the
analysis, and all 20 subjects were included in the PK analysis set and
safety analysis set. Twenty subjects received carotegrast methyl alone,
and carotegrast methyl and rifampicin in combination. Plasma drug
concentration profiles of carotegrast methyl, carotegrast, M-I, M-II and
carotegrast-gluc after single oral administration of carotegrast methyl
in the presence and absence of rifampicin under fasting conditions are
shown in Figure 3. The PK parameters are shown in Table 2.
Drug-drug interactions between
carotegrast methyl and its metabolites, and rifampicin are shown in
Table 3.