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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flonoltinib Maleate Tablets treament group | Experimental | Subjects in this group will take Flonoltinib Maleate Tablets |
|
| placebo group | Placebo Comparator | Subjects in this group will take Flonoltinib Maleate Tablets placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flonoltinib Maleate Tablets | Drug | Day 1 will be used for drug administration, and Day 1~Day 7 will be used for experimental data collection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | time to peak | 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 | 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 | 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 | 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 | 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-ā |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | According to the experimental schedule D-14-D7 or early termination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaolan Yong, bachelor | Chengdu Xinhua Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu Xinhua Hospital | Chengdu | Sichuan | 610000 | China |
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| Flonoltinib Maleate Tablets placebo | Drug | Day 1 will be used for drug administration, and Day 1~Day 7 will be used for experimental data collection. |
|
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The area under the blood drug concentration-time curve from 0 to infinity time
| 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 |
| Vz/F | apparent volume of distribution | 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 urineļ¼that is collected from the 50 mg and 150mg dose groups. | 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 | 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 |