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.