2.4 Study Design and regimen
The screening was performed from day-7 to day-1. Eligible subjects were admitted to the Phase I clinical trial ward on day-1, provided a light diet in the evening, and then fasted for 10 hours. On day 1, each subject was administered famitinib as a single oral 25 mg dose. Blood samples were collected before administration (within 1 h), 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 144 and 192 hours after dosing. On day 10 through 22, subjects were orally daily administered 40 mg of omeprazole at least 0.5 hours before breakfast, with the exception of day 15. On day 15, famitinib (25 mg) was administered concomitantly with omeprazole (40 mg), and the collection of the blood samples was the same as that on day 1. During the study period, all drugs were administered with approximately 240 mL water under a fasting condition, on day 1 and day 15, water was forbidden within 1 hour before and after the study drug administration, and food was to be avoided within 4 hours after administration. On day 23, all subjects were discharged after examination in the morning. Subjects returned to the research center for follow-up or telephone follow-up from day 28 to day 30. A safety assessment was performed during the entire test period. A flowchart of this study is presented in Figure 1.