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The study is being conducted to compare the pharmacokinetics and safety of HRS-7535 in subjects with mild to moderate hepatic impairment and normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | Subjects with mild hepatic impairment. |
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| Treatment group B | Experimental | Subjects with moderate hepatic impairment. |
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| Treatment group C | Experimental | Subjects with normal hepatic function. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7535 Tables | Drug | Oral HRS-7535 tables. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration of HRS-7535 (Cmax) | Post-dose at day 1 to day 4. | |
| Area under the concentration curve from time 0 to the last quantifiable concentration (AUC0-t) | Post-dose at day 1 to day 4. | |
| Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf) | Post-dose at day 1 to day 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum plasma concentration (Tmax) | Post-dose at day 1 to day 4. | |
| Terminal half-life (t1/2) | Post-dose at day 1 to day 4. | |
| Apparent clearance (CL/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial Infectious Disease Hospital | Zhengzhou | Henan | 450015 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Post-dose at day 1 to day 4. |
| Apparent volume of distribution (Vz/F) | Post-dose at day 1 to day 4. |
| Adverse events (AEs) | Screening period up to Day 7. |