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This study is designed to evaluate the safety and pharmacokinetics of Fluzoparib in subjects with impaired liver function in comparison with healthy subjects ,to develop dose recommendations for patients with hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Hepatic Function | Experimental |
| |
| Mild Hepatic Impairment | Experimental |
| |
| Moderate Hepatic Impairment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | A single oral dose of 50 mg Fluzoparib will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of Fluzoparib: Cmax | through study completion, an averange of half year | |
| Pharmacokinetics parameters of Fluzoparib: AUC0-t | through study completion, an averange of half year | |
| Pharmacokinetics parameters of Fluzoparib: AUC0-∞(if available) | through study completion, an averange of half year |
| Measure | Description | Time Frame |
|---|---|---|
| Other pharmacokinetics parameters of Fluzoparib: Tmax | through study completion, an averange of half year | |
| plasma protein binding rate of Fluzoparib | through study completion, an averange of half year |
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Inclusion Criteria for subjects with impaired liver function:
Exclusion Criteria impaired liver function:
Inclusion Criteria for subjects with normal liver function:
Exclusion Criteria normal liver function:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Infectious Diseases Hospital | Zhengzhou | Henan | China |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
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| The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0) | through study completion, an averange of half year |
| Other pharmacokinetics parameters of Fluzoparib: T1/2 etc. | through study completion, an averange of half year |