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To evaluate the effect of oral itraconazole on the pharmacokinetics of SHR0302 in healthy subjects.
To evaluate the safety and tolerability of oral SHR0302 and itraconazole monotherapy and combination use in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | itraconazole and SHR0302 tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| itraconazole、 SHR0302 tablets | Drug | Itraconazole 7 times and SHR0302 tablets twice. On the 8th day of this, itraconazole and SHR0302 tablets were taken simultaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SHR0302 and its main metabolite AUC0-t | day 1 to day 11 | |
| SHR0302 and its main metabolite AUC0-inf | day 1 to day 11 | |
| SHR0302 and its main metabolite Cmax | day 1 to day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| SHR0302 and its main metabolite Tmax (SHR0302 only) | day 1 to day 11 | |
| SHR0302 and its main metabolite t1/2 (SHR0302 only) | day 1 to day 11 | |
| SHR0302 and its main metabolite CL/F (SHR0302 only) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Hospital of Changsha | Changsha | Hunan | 410000 | 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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itraconazole and SHR0302 tablets are used in combination
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| day 1 to day 11 |
| SHR0302 and its main metabolite Vz/F (SHR0302 only) | day 1 to day 11 |
| Adverse events | Day 1 to Day 17 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |