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This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of Chiglitazar following administration of a single oral dose in subjects with renal impairment compared to subjects with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Renal Function | Experimental | Subjects with normal renal function will receive a single 48 mg oral dose of Chiglitazar |
|
| Severe Renal Impairment | Experimental | Subjects with severe renal impairment will receive a single 48 mg oral dose of Chiglitazar |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiglitazar | Drug | Oral single dose 48 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration | 4 days |
| AUC0-t and AUC0-inf | Area under of the curve (AUC0-t and AUC0-inf) | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LiYan Miao | First Affiliated Hospital of Suzhou Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 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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| ID | Term |
|---|---|
| C515629 | chiglitazar |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |