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To assess the relative bioavailability of SHR0302 oral solution and tablet in healthy subjects.
To assess the safety and tolerability of a single dose of SHR0302 oral solution and tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group ARM 1 | Experimental | SHR0302 tablets, then SHR0302 oral solution |
|
| Treatment group ARM 2 | Experimental | SHR0302 oral solution, then SHR0302 tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 | Drug | SHR0302 oral solution 1 time, SHR0302 tablets 1 time |
|
| Measure | Description | Time Frame |
|---|---|---|
| SHR0302 and its main Pk parameter, AUC0-t | day 1 to 8 | |
| SHR0302 and its main Pk parameter, AUC0-inf | day 1 to 8 | |
| SHR0302 and its main Pk parameter, Cmax | day 1 to 8 | |
| Relative bioavailability (F%) value between SHR0302 oral solution and SHR0302 tablet: F% = AUC0-t (oral solution) / AUC0-t (tablet) ×100% | day 1 to 8 |
| Measure | Description | Time Frame |
|---|---|---|
| SHR0302 and its main Pk parameter, Tmax (SHR0302 only) | day 1 to 8 | |
| SHR0302 and its main Pk parameter, t1/2 (SHR0302 only) | day 1 to 8 | |
| SHR0302 and its main Pk parameter, CL/F (SHR0302 only) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | 100005 | China |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000615713 | ivarmacitinib |
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| day 1 to 8 |
| SHR0302 and its main Pk parameter, Vz/F (SHR0302 only) | day 1 to 8 |
| Adverse events | day 1 to 12 |