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The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of Fuzuloparib Capsules in healthy subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fed+ Fasted | Experimental | The first cycle with high-fat meal, the second cycle under fasting. |
|
| Fasted + Fed | Experimental | The first cycle under fasting, the second cycle with high-fat meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fuzuloparib | Drug | Fuzuloparib Capsules; 150mg; single dose per cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | day 1 to day 10 | |
| Area under the plasma concentration versus time curve from time 0 to last time of measurable concentration (AUC0-t) | day 1 to day 10 | |
| Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-∞ ) | day 1 to day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events/serious adverse events | from ICF signing date to approximate day 23 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wannan Medical College Yijishan Hospital | Wuhu | Anhui | 241000 | China |
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There will be 20 volunteers to receive the treatment, and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic and safety.
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