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The study is being conducted to evaluate the pharmacokinetic, and safety of two sizes of SHR4640 tablets in healthy adults, to explore the bioequivalence between two sizes of SHR4640 tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR4640 | Drug | SHR4640, 2.5mg*4 - 10mg*1 |
| |
| SHR4640 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of SHR4640: Cmax | 0 hour to 72 hour after administration | |
| PK parameters of SHR4640: AUC0-t | 0 hour to 72 hour after administration | |
| PK parameters of SHR4640: AUC0-inf | 0 hour to 72 hour after administration |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of SHR4640: Tmax | 0 hour to 72 hour after administration | |
| PK parameters of SHR4640: t1/2 | 0 hour to 72 hour after administration | |
| PK parameters of SHR4640: CL/F |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hospital Affilated to Shandong First Medical University | Jinan | Shandong | 250013 | China |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000720748 | ruzinurad |
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Randomized, Open, Single Dose, Two Sequences, Two Cycles, Self-Crossover Control
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| Drug |
SHR4640, 10mg*1 - 2.5mg*4 |
|
| 0 hour to 72 hour after administration |
| PK parameters of SHR4640: Vz/F | 0 hour to 72 hour after administration |
| Adverse events | from ICF signing date to approximate day 13 |