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The study is being conducted to evaluate the safety, and the relative bioavailability of SHR0302 tablets with three different formulations in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental |
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| group B | Experimental |
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| group C | Experimental |
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| group D | Experimental |
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| group E | Experimental |
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| group F | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 | Drug | Group A subjects were given oral F1 、F2 and F3 version SHR0302 |
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| Measure | Description | Time Frame |
|---|---|---|
| The peak plasma concentration (Cmax) of SHR0302. | Based on the PK concentration data set, calculate the peak plasma concentration of SHR0302 by non-compartmental analysis. | 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose. |
| Area Under the Plasma Concentration Versus Time Curve (AUC) of SHR0302. | Based on the SHR0302 plasma concentration data set, calculate the Area Under the Plasma Concentration Versus Time Curve of SHR0302 by non-compartmental analysis. | 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose. |
| The relative bioavailability of SHR0302 tablets with 3 different formulations. | The mixed effect model is used to estimate the least square mean difference and 90% confidence interval between different formulations, and then take the antilog to obtain the estimate of the ratio of the least square geometric mean of the corresponding PK parameter and the 90% confidence interval Time. | through study completion, an average of 1 month. |
| Measure | Description | Time Frame |
|---|---|---|
| The Peak Time (Tmax) of SHR0302. | Based on the SHR0302 plasma concentration data set, calculate the time to reach peak plasma concentration of SHR0302 by non-compartmental analysis. | 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose. |
| The Elimination half-life (T1/2) of SHR0302. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Beijing,Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
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| ID | Term |
|---|---|
| C000615713 | ivarmacitinib |
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The relative bioavailability of SHR0302 tablets with three different formulations
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| SHR0302 |
| Drug |
Group B subjects were given oral F1 、F3 and F2 version SHR0302 |
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| SHR0302 | Drug | Group C subjects were given oral F2 、F1 and F3 version SHR0302 |
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| SHR0302 | Drug | Group D subjects were given oral F2 、F3 and F1 version SHR0302 |
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| SHR0302 | Drug | Group E subjects were given oral F3 、F1 and F2 version SHR0302 |
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| SHR0302 | Drug | Group F subjects were given oral F3 、F2 and F1 version SHR0302 |
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Based on the SHR0302 plasma concentration data set, calculate the time required for the blood concentration of SHR0302 to drop by half. |
| 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose. |
| The Clearance (CL/F) of SHR0302. | Based on the SHR0302 plasma concentration data set, calculate the clearance of SHR0302 by non-compartmental analysis. | 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose. |
| The apparent volume of distribution (Vz/F) of SHR0302. | Based on the SHR0302 plasma concentration data set, calculate the apparent volume of distribution of SHR0302 by non-compartmental analysis. | 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose. |
| Incidence of adverse events. | laboratory abnormalities (based on hematology, biochemistry, coagulation function, and urinalysis tests), vital sign measurements (include blood pressure, pulse rate, respiratory rate, and body temperature) and 12-Lead electrocardiogram. | through study completion, an average of 1 month |