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The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640 and Febuxostat interaction in patients with Hyperuricemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR4640 | Experimental | SHR4640 dose1 Oral Tablet Day1~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd. |
|
| Febuxostat | Experimental | Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8~Day14 qd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR4640 dose1 | Drug | Tablet,dose1,QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma | Day1 to Day 14 | |
| Area under the plasma concentration versus time curve (AUC) of SHR4640 and Febuxostat from plasma | Day1 to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma | Day1 to Day 14 | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events | Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cao Yu | Contact | 0532-82911767 | Caoyu1767@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of QingDao University | Recruiting | Qingdao | Shandong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36131360 | Derived | Wang C, Yu Q, Jiang X, Deng Y, Sun F, Li X, Tao Y, Lin P, Ma Y, Zhu Y, Li C, Cao Y. A Drug-Drug Interaction Study of a Novel Selective Urate Reabsorption Inhibitor, SHR4640, and Xanthine Oxidase Inhibitor, Febuxostat, in Patients With Primary Hyperuricemia. J Clin Pharmacol. 2023 Feb;63(2):239-249. doi: 10.1002/jcph.2159. Epub 2022 Oct 20. |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Febuxostat dose2 |
| Drug |
Tablet,dose2,QD |
|
| Clinical significant changes from Day-21 up to Day 29 |