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The purpose of this open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR0302 fasted or fed), crossover study was to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR0302 and mass balance study in 14 healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR0302 fasted to fed | Experimental | SHR0302 tablets (10 mg) administered on day 1 fasting, and day 7 with high fat, high calorie breakfast |
|
| SHR0302 fed to fasted | Experimental | SHR0302 tablets (10 mg) administered on day 1 with high fat, high calorie breakfast, and day 7 fasting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 | Drug | SHR0302 tablets (10 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (Cmax) of SHR0302 | up to 72 hrs postdose on day1 and day7 | up to 72 hrs postdose |
| The area under the plasma concentration-time curve (AUC) of SHR0302 | up to 72 hrs postdose on day1 and day7 | up to 72 hrs postdose |
| The accumulative excretion rate of SHR0302 and its metabolites in urine and feces | up to 96 hrs postdose on day1 and day7 | up to 96 hrs postdose |
| Measure | Description | Time Frame |
|---|---|---|
| The number of volunteers with adverse events as a measure of safety | required last visit via telephone during D11 to D21 | up to Day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengyu Guan, MD | Contact | 86-21-50118402 | guanchengyu@hrs.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chen Yu, BS | Shanghai Xuhui Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000615713 | ivarmacitinib |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |