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| Name | Class |
|---|---|
| Hunan Cancer Hospital | OTHER |
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The purpose of this study is to evaluate the Effect of fluconazole on the Pharmacokinetics of Fluzoparib in Healthy male Adults
Subjects received oral Fluzoparib 20 mg after D1 single meal, D2-D4 for washing period, D5 started oral fluconazole 400 mg/day/day after meal, continuous administration for 6 days to D10, D8 meal After oral administration of fluconazole 400 mg, a single oral dose of Fluzoparib 20 mg was given immediately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | PARP inhibitor |
| |
| Fluconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration(Cmax) of Fluzoparib | Cmax | through study completion,up to 24 weeks |
| Area under the Plasma Concentration-time curve From 0-t of Fluzoparib | AUC0-t | through study completion,up to 24 weeks |
| Area under the Plasma Concentration-time curve From 0 to infinity of Fluzoparib | AUC0-∞ | through study completion,up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety in terms of Adverse Events Assessments | NCI-CTC AE 5.0 | through study completion,up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Early Cancer Research Center of Hunan Cancer Hospital | Hunan | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
inhibitor |
|