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The purpose of this study is to investigate relative bioavailability during the new and traditional formulations of SHR6390 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Intervention: Drug: SHR6390 new formulation 1(T1) in the first period; SHR6390 new formulation 2 (T2) in the second period; SHR6390 traditional formulation (R) in the last period |
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| Sequence 2 | Experimental | Intervention: Drug: SHR6390 traditional formulation (R) in the first period; SHR6390 new formulation 1 (T1) in the second period; SHR6390 new formulation 2 (T2) in the last period |
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| Sequence 3 | Experimental | Intervention: Drug: SHR6390 new formulation 2(T2) in the first period; SHR6390 traditional formulation (R) in the second period; SHR6390 new formulation 1 (T1) in the last period |
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| Sequence 4 | Experimental | Intervention: Drug: SHR6390 new formulation 1(T1) in the first period; SHR6390 traditional formulation (R) in the second period; SHR6390 new formulation 2 (T2) in the last period |
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| Sequence 5 | Experimental | Intervention: Drug: SHR6390 new formulation 2(T2) in the first period; SHR6390 new formulation 1 (T1) in the second period; SHR6390 traditional formulation (R) in the last period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR6390 | Drug | SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles |
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| Measure | Description | Time Frame |
|---|---|---|
| Fr | Relative bioavailability of the two new formulations on SHR6390 | Day1~Day35 |
| Cmax | Maximum concentration of SHR6390 | Day1~Day35 |
| AUC0-t | Area under the concentration-time curve from time zero to time t of SHR6390 | Day1~Day35 |
| AUC0-∞ | Area under the concentration-time curve extrapolated to infinity of SHR6390 | Day1~Day35 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 470071 | China |
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| Sequence 6 | Experimental | Intervention: Drug: SHR6390 traditional formulation (R) in the first period; SHR6390 new formulation 2 (T2) in the second period; SHR6390 new formulation 1 (T1) in the last period |
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