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The objective of the study is to assess the Safety and Efficacy of SHR4640 and Febuxostat in patients with Hyperuricemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | SHR4640 dose1 Oral Tablet plus Febuxostat dose1 Oral Tablet Day1~Day28 qd. |
|
| Treatment group B | Experimental | SHR4640 dose1 Oral Tablet plus Febuxostat dose2 Oral Tablet Day1~Day28 qd. |
|
| Treatment group C | Experimental | SHR4640 dose2 Oral Tablet plus Febuxostat dose3 Oral Tablet Day1~Day28 qd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR4640 dose1 plus Febuxostat dose1 | Drug | Tablet,dose1,QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events(AEs) and Serious Adverse Events(SAEs) | Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events, incidence of drug related adverse events (safety and tolerability) | Up to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with a serum uric level≤360μmol/L | At week1, 2, 3 and 4 | |
| Percentage change from baseline in serum uric level . | At week1, 2, 3 and 4 | |
| Actual change from baseline in serum uric level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Yi | Contact | 028-85423237 | hxyyhfb@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Liu Yi | West China Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| SHR4640 dose1 plus Febuxostat dose2 |
| Drug |
Tablet,dose1, dose2 QD |
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| SHR4640 dose2 plus Febuxostat dose3 | Drug | Tablet,dose2, dose3 QD |
|
| At week1, 2, 3 and 4 |