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The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640, Febuxostat and Colchicine interaction in patients with gout.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Colchicine 0.5 mg Oral Tablet Day-14~Day16 qd, Febuxostat 80 mg Oral Tablet Day1 and Day8 qd, SHR4640 10 mg Oral Tablet Day3~Day8 qd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Day-14~Day16 qd |
| |
| Febuxostat |
| Measure | Description | Time Frame |
|---|---|---|
| Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma | PK profile | Clinical significant changes from baseline up to Day 8 |
| Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma | PK profile | Clinical significant changes from baseline up to Day 8 |
| Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma | PK profile | Clinical significant changes from baseline up to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events | Safety issue | Clinical significant changes from Day-14 up to Day 16 |
| Changes in Laboratory Values | Safety issue |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| D000069465 | Febuxostat |
| C000720748 | ruzinurad |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
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| Drug |
Day1 and Day8 qd |
|
| SHR4640 | Drug | Day3~Day8 qd |
|
| Clinical significant changes from Day-14 up to Day 16 |
| Changes in Electrocardiogram | Safety issue | Clinical significant changes from Day-14 up to Day 16 |
| Changes in Vital Signs Parameters | Safety issue | Clinical significant changes from Day-14 up to Day 16 |
| 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 |
| D009930 |
| Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |