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| Name | Class |
|---|---|
| The Third Xiangya Hospital of Central South University | OTHER |
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The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of Fluzoparib in Healthy male Adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | Drug: Fluzoparib Drug: Omeprazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | PARP inhibitor |
| |
| Omeprazole |
| 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 to 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-∞ (if available) | through study completion, up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety in terms of Adverse Events Assessments | 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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| Name | Affiliation | Role |
|---|---|---|
| Guoping Yang, PhD | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The third xiangya hospital Hospital,of central south university | Changsha | Hunan | 410013 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33420642 | Derived | Li L, Xiang YX, Yang GP, Zhang XF, Yang XY, Yang S, Huang J. Pharmacokinetic effects of proton pump inhibitors on the novel PARP inhibitor fluzoparib: a single-arm, fixed-sequence trial in male healthy volunteers. Invest New Drugs. 2021 Jun;39(3):796-802. doi: 10.1007/s10637-020-01034-w. Epub 2021 Jan 9. |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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repeated oral doses of Omeprazole on the pharmacokinetic profile of a single dose of Fluzoparib
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| Drug |
proton pump inhibitor |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |