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The primary objective of the study is to evaluate the effect of high-fat diet on pharmacokinetics of healthy Chinese male adult subjects after oral administration of SHR2554 tablets.
The secondary objective of the study is to evaluate the safety of single dose of SHR2554 orally in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | Drug: SHR2554 fasted in P1, high-fat diet in P2 SHR2554 administration in fasted condition in period 1, SHR2554 administration after high-fat diet in period 2 |
|
| Treatment group B | Experimental | Drug: SHR2554 high-fat diet in P1, fasted in P2 SHR2554 administration after high-fat diet in period 1, SHR2554 administration in fasted condition in period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR2554 | Drug | SHR2554 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: Cmax of SHR2554 | Peak Plasma Concentration (Cmax) of SHR2554 | Day 1 and Day 8 of the single dose |
| Pharmacokinetics parameter: AUC of SHR2554 | Area under the plasma concentration versus time curve (AUC) of SHR2554 | Day 1 and Day 8 of the single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Henan | China |
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