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The primary objective of the study is to evaluate the bioequivalence of two different specification of reference preparation capsules (10 mg/capsule, 40 mg/capsule and 100 mg/capsule, 1 capsule each) and test preparations capsules (50 mg/capsule×3). Two different specifications of fluzoparib was provided by Jiangsu HengRui Pharmaceutical Co., Ltd.
The secondary objective of the study is to evaluate the safety of test preparations and reference preparation fluzoparib capsules of different specifications in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR sequence group | Experimental |
| |
| RT sequence group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | the first period: test preparation; the second period: reference preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Fluzoparib | Up to Day 10 | |
| Area Under the Plasma Concentration(AUC) of Fluzoparib | Up to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Up to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The affiliated hospital of QingDao university | Qingdao | Qingdao | China |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
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Single dose of oral administration of fluzoparib capsules
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No Masking
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| Fluzoparib | Drug | the first period: reference preparation the second period: test preparation |
|