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TThe study is being conducted to evaluate the relative bioavailability, pharmacokinetics and safety of different tablet processes of SHR2554 in healthy adult subjects.
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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 |
|---|---|---|---|---|
| New Process SHR2554 tablet、Former Process SHR2554 tablet | Drug | New Process, 350 mg SHR2554 tablets on study day 1 - Former Process, 350 mg SHR2554 tablets on study day 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | day 1 to day 11 | |
| AUC0-t | day 1 to day 11 | |
| AUC0-∞ | day 1 to day 11 | |
| Tmax | day 1 to day 11 | |
| t1/2 | day 1 to day 11 | |
| CL/F | day 1 to day 11 | |
| Vz/F | day 1 to day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events/serious adverse events | from ICF signing date to approximate day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
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A single-centre, single-dose, random, open, two-period, cross-over relative bioavailability study.
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| Former Process SHR2554 tablet、New Process SHR2554 tablet | Drug | Former Process, 350 mg SHR2554 tablets on study day 1 - New Process, 350 mg SHR2554 tablets on study day 8 |
|
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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