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The primary objective of this study is to evaluate pharmacokinetics of HRS-1301 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 |
|---|---|---|---|
| HRS-1301 Tablet Group | Experimental | Treatment for oral medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1301 Tablet | Drug | HRS-1301 tablet, oral medication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax). | Pharmacokinetic parameters of HRS-1301 in plasma. | 0 hour to 8 days after dosing. |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last). | Pharmacokinetic parameters of HRS-1301 in plasma. | 0 hour to 8 days after dosing. |
| Area under the concentration-time curve from time zero to infinity (AUC0-inf). | Pharmacokinetic parameters of HRS-1301 in plasma. | 0 hour to 8 days after dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum concentration (Tmax). | Pharmacokinetic parameters of HRS-1301 in plasma. | 0 hour to 8 days after dosing. |
| Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Wang, PhD | Contact | +86-0518-81220121 | ying.wang.yw30@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | 610072 | China |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The Pharmacokinetics (PK), safety and Pharmacodynamics (PD) characteristics of a single oral administration of HRS-1301 tablets in subjects with mild, moderate and severe renal insufficiency and healthy subjects were compared using a single-dose, open-label design.
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Pharmacokinetic parameters of HRS-1301 in plasma.
| 0 hour to 8 days after dosing. |
| Elimination half-life (t1/2). | Pharmacokinetic parameters of HRS-1301 in plasma. | 0 hour to 8 days after dosing. |
| Apparent clearance (CL/F). | Pharmacokinetic parameters of HRS-1301 in plasma. | 0 hour to 8 days after dosing. |
| Apparent volume of distribution (Vz/F). | Pharmacokinetic parameters of HRS-1301 in plasma. | 0 hour to 8 days after dosing. |
| Cumulative drug excretion in urine (Ae,urine). | Pharmacokinetic parameters of HRS-1301 in urine. | 0 hour to 6 days after dosing. |
| Cumulative drug excretion fraction in urine (fe,urine). | Pharmacokinetic parameters of HRS-1301 in urine. | 0 hour to 6 days after dosing. |
| Incidence of adverse events (AEs). | Safety and tolerability. | 0 hour to 8 days after dosing. |
| Incidence of serious adverse events (SAEs). | Safety and tolerability. | 0 hour to 8 days after dosing. |