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This study is to evaluate the single-dose pharmacokinetics (PK) and safety of Yimitasvir phosphate capsule in participants with End-stage renal disease without hemodialysis using matched healthy participants as a control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with renal impairment | Experimental | Participants with End-stage renal disease will receive a single dose of Yimitasvir Phosphate Capsule. |
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| Participants with normal renal function | Experimental | Participants with normal renal function will receive a single dose of Yimitasvir Phosphate Capsule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yimitasvir Phosphate Capsule | Drug | DAG181 100 mg (100 mg Capsule) administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics (PK) parameters of DAG181 as measured by AUC | AUC is defined as the concentration of drug area under the curve | From Days 1-5 |
| Plasma pharmacokinetics (PK) parameters of DAG181 as measured by Cmax | Cmax is defined as the maximum concentration of drug | From Days 1-5 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | The incidence of adverse events will be summarized | From Days 1-5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jia Miao, Doctor | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610000 | 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 |
|---|---|
| C000628665 | yimitasvir |
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|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |