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This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of HSK21542 in subjects with mild, moderate and severe renal impairment compared to the matched control subjects with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Renal Impairment | Experimental |
| |
| Moderate Renal Impairment | Experimental |
| |
| Severe Renal Impairment | Experimental |
| |
| Normal Renal function | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK21542 Injection | Drug | 1ug/kg bolus for 2min±5s |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The maximun plasma concentration of HSK21542 | From the start to 240 hours after bolus |
| AUC0-t | Area under the concentration-time curve from time zero to time of last quantifiable concentration | From the start to 240 hours after bolus |
| AUC0-inf | Area under the concentration-time curve from time zero extrapolated to infinite time | From the start to 240 hours after bolus |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time of maximum concentration | From the start to 240 hours after bolus |
| t1/2 | half-life | From the start to 240 hours after bolus |
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Inclusion Criteria:
Subjects with renal impairment(RI):
Subjects with normal renal function :
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meixia Chen, PhD | Contact | 028-67258779 | chenmeixia@haisco.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Zhao, PhD | Qianfoshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Qianfoshan Hospital | Recruiting | Jinan | Shandong | 250014 | China |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Vz | Volume of distribution associated with the terminal phase | From the start to 240 hours after bolus |
| CL | Plasma clearance | From the start to 240 hours after bolus |
| Ae | Cumulative urinary recovery of unchanged drug | Predose and 72 hours after dosing |
| Fe | Cumulative urinary recovery fraction of unchanged drug | Predose and 72 hours after dosing |
| CLr | Renal clearance | Predose and 72 hours after dosing |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |