The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial. It is planned to enroll 28 healthy subjects. Subjects will receive famitinib malate on Day1 and Day13.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
TR Group: famitinib malate T on day 1, famitinib malate R on day 13.
RT Group: famitinib malate R on day 1, famitinib malate T on day 13.
The First Affiliated Hospital of USTC
Jinan, Jinan, China
Maximum observed plasma concentration (Cmax) of Famitinib
Time frame: from Day1 to Day9 after the first cycle (each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days)
Area under the plasma concentration versus time curve (AUC0-t) of Famitinib
Time frame: from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days)
Area under the plasma concentration versus time curve (AUC0-∞) of Famitinib
Time frame: from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days)
Time to maximum observed plasma concentration (Tmax) of Famitinib
Time frame: from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days)
Elimination half-life (T1/2) of Famitinib
Time frame: from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days)
Apparent oral clearance (CL/F) of Famitinib
Time frame: from Day1 to Day9(each cycle is 9 days) after the first cycle and from Day13 to Day21 after the second cycle(each cycle is 9 days)
Maximum observed plasma concentration (Cmax) of SHR116637
Time frame: from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days)
Area under the plasma concentration versus time curve (AUC0-t) of SHR116637
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days)
Area under the plasma concentration versus time curve (AUC0-∞) of SHR116637
Time frame: from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days)
Time to maximum observed plasma concentration (Tmax) of SHR116637
Time frame: from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days)
Time to elimination half-life (T1/2) of SHR116637
Time frame: from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days)
Apparent oral clearance (CL/F) of SHR116637
Time frame: from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days)
Number of subjects with adverse events and the severity of adverse events
Time frame: from Day1 to Day21 after the first dose