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To evaluate the safety and tolerability of RSS0343 tablets in healthy subjects after single and multiple oral administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1: RSS0343 tablets or placebo | Experimental |
| |
| Treatment group 2: RSS0343 tablets or placebo | Experimental |
| |
| Treatment group 3: RSS0343 tablets or placebo | Experimental |
| |
| Treatment group 4: RSS0343 tablets or placebo | Experimental |
| |
| Treatment group 5: RSS0343 tablets or placebo | Experimental |
| |
| Treatment group 6: RSS0343 tablets or placebo | Experimental |
| |
| Treatment group 7: RSS0343 tablets or placebo | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSS0343 tablets ;placebo | Drug | RSS0343 tablets and placebo were given orally as a single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | The observation lasted until the 61th day |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The observation lasted until the 33th day | |
| AUC0-t | The observation lasted until the 33th day | |
| AUC0-inf |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital) | Shandong | Jinan | 250013 | China |
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| Treatment group 8: RSS0343 tablets or placebo | Experimental |
|
| RSS0343 tablets ;placebo | Drug | RSS0343 tablets and placebo were taken orally multiple times |
|
| The observation lasted until the 33th day |
| Tmax | The observation lasted until the 33th day |
| t1/2 | The observation lasted until the 33th day |
| CL/F | The observation lasted until the 33th day |
| Vz/F | The observation lasted until the 33th day |
| Ae,urine | The observation lasted until the 33th day |
| fe,urine | The observation lasted until the 33th day |
| Relative bioavailability of premeal and postmeal administration | The observation lasted until the 16th day |
| Neutrophil elastase (NE) activity in peripheral blood after repeated oral administration of RSS0343 | The observation lasted until the 61th day |