Evaluate the safety , tolerability and pharmacokinetics of Flonoltinib Maleate tablets in a single increasing dose oral administered to healthy adult Chinese subjects.Subjects will divide into experimental group and placebo group, conduct single oral administration safety and tolerability test group by group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
40
Day 1 will be used for drug administration, and Day 1\~Day 7 will be used for experimental data collection.
Day 1 will be used for drug administration, and Day 1\~Day 7 will be used for experimental data collection.
Chengdu Xinhua Hospital
Chengdu, Sichuan, China
Tmax
time to peak
Time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
Cmax
maximum concentration
Time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
t1/2
Terminal phase elimination half-life
Time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
CL/F
Apparent clearance rate
Time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
AUC0-t
Area under the blood concentration-time curve from 0 o 'clock to the last measurable concentration at collection time t
Time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
AUC0-∞
The area under the blood drug concentration-time curve from 0 to infinity time
Time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
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Vz/F
apparent volume of distribution
Time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
Ae0-144hours and Ae%
The pharmacokinetic statistical parameters of urine are the cumulative excretion (Ae0-144hours) and excretion rate (Ae%) of prototype drugs and major metabolites in urine,that is collected from the 50 mg and 150mg dose groups.
Time frame: Day1 Within 2hours before administration and 0~4 hours, 4~8 hours, 8~12 hours, 12~24 hours, 24~36 hours, 36~48 hours, 48~72 hours, 72~96hours, 96~120 hours, 120~144 hours after administration
Ae0-144hours and Ae%
The statistical parameters of fecal pharmacokinetics are the cumulative excretion of prototype drugs and major metabolites in feces (Ae0-144hours) and excretion rate (Ae%) ,that is collected from the 50 mg and 150mg dose groups
Time frame: 1 blank fecal sample before administration and after administration: 0~24 hours, 24~48 hours,48~72 hours, 72~96hours, 96~120 hours, 120~144 h ours
security indicators
Observe the changes in vital signs, physical examination, clinical symptoms, laboratory tests, ECG, and occurrence of adverse events of the subjects after medication.
Time frame: According to the experimental schedule D-14-D7 or early termination