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The objective of the study is to assess the tolerance, pharmacokinetic and pharmacodynamic properties of multiple dose adminstration of SHR4640 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 1mg SHR4640 or placebo |
|
| Cohort 2 | Experimental | 2.5mg SHR4640 or placebo |
|
| Cohort 3 | Experimental | 5mg SHR4640 or placebo |
|
| Cohort 4 | Experimental | 10mg SHR4640 or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR4640 | Drug | Day1~Day7:oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Clinical significant changes from baseline up to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration(Cmax)(of single dose and at stable status) | Up to Day 10 | |
| Area under the plasma concentration versus time curve(AUC)(of single dose and at stable status) | Up to Day 10 | |
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Inclusion Criteria:
3.4 mg/dL≤Screening serum urate level≤7 mg/dL;
4.Medically stable based on physical examination, laboratory results, vital sign measurements, 12-lead electrocardiogram, abdomen B-ultrasound and Chest X-ray examination at screening.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The South West Hospital | Chongqing | Chongqing Municipality | 400042 | China |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| C000720748 | ruzinurad |
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| placebo | Drug | Day1~Day7:oral administration |
|
| Half-time(T1/2)(of single dose and at stable status) |
| Up to Day 10 |
| Time to the peak plasma concentration(Tmax)(of single dose and at stable status) | Up to Day 10 |
| Changes in serum uric acid concentration from baseline | Up to Day 10 |
| Changes in urinary uric acid excretion from baseline | Up to Day 10 |
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |