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The study is being conducted to assess the safety and tolerability of HRS4800 after multiple oral administration with different dose regimens in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS4800 | Drug | HRS4800 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of the Adverse Events that are related to the treatment from baseline to Day36 | from baseline to Day36 | |
| The severity of the Adverse Events that are related to the treatment from baseline to Day36 | from baseline to Day36 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, Peak Concentration; | Day1 | |
| AUC0-tau, Area under the curve during a dose interval; | Day1 | |
| Tmax; The time to reach peak concentration; |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510260 | China |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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HRS4800 Tablet compared with placebo
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| Drug |
Placebo |
|
| Day1 |
| Css,max, Peak Concentration at steady state; | Day14 |
| AUCss, 0-tau, Area under the curve during a dose interval at steady state; | Day14 |
| AUC0-inf, Area under the curve from 0 to infinite; | Day14 |
| Tmax, the time to reach peak concentration; | Day14 |
| Ctrough trough concentration at steady state; | Day14 |
| Rac, , accumulation factor; | Day14 |
| t1/2, terminal half life; | Day14 |
| CL/F, apparent clearance at steady state ; | Day14 |
| Vss/F; apparent volume of distribution at steady state | Day14 |
| SHR175593 concentration on Day1 and day 14 | Day1 and day 14 |
| QTc on Day1 and Day 14 | Day1 and day 14 |