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The primary objective is to evaluate pharmacokinetics of HRS-1893 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Renal Function Group | Experimental |
| |
| Mild Renal Impairment Group | Experimental |
| |
| Moderate Renal Impairment Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1893 | Drug | HRS-1893 tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | 0 hour to 16 days after the dosing. | |
| Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) | 0 hour to 16 days after the dosing. | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) | 0 hour to 16 days after the dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum plasma concentration (Tmax) | 0 hour to 16 days after the dosing. | |
| Terminal half-life (t1/2) | 0 hour to 16 days after the dosing. | |
| Apparent clearance (CL/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| 0 hour to 16 days after the dosing. |
| Apparent volume of distribution (Vz/F) | 0 hour to 16 days after the dosing. |
| Cumulative excretion (Ae) | 0 hour to 16 days after the dosing. |
| Plasma protein binding rate (PPB) | 0 hour to 16 days after the dosing. |
| Incidence and severity of adverse events (AEs) | 0 hour to 16 days after the dosing. |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |