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This study is a Phase I, single-dose, open-label trial designed to evaluate the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with renal impairment compared to participants with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Renal Function | Experimental |
| |
| Mild Renal Impairment | Experimental |
| |
| Moderate Renal Impairment | Experimental |
| |
| Severe Renal Impairment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VC005 Tablets | Drug | Oral single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve(AUC) | Day1-Day3 | |
| Maximum Observed Plasma Concentration (Cmax) | Day1-Day3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaojuan lai | Contact | 15358160458 | lai_xiaojuan@vcarepharmatech.com |
| Name | Affiliation | Role |
|---|---|---|
| Huan Zhou | The First Affiliated Hospital of Bengbu Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical University | Recruiting | Bengbu | Anhui | 233000 | 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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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |