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The purpose of this study is to evaluate and compare the pharmacokinetics of SHR0302 two different kind tablets in Healthy subjects after administration two kind tablets (quick release tablets and sustained-release tablets).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR0302 quick release tablet and sustained-release tablet | Experimental |
| |
| SHR0302 sustained-release tablet and quick release tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 quick release tablets | Drug | SHR0302 quick release tablets 8 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of SHR0302: Cmax | Based on pre-dose, 0.25-72 hours post-dose sampling times after administration on Day 1 and Day 5 | |
| PK parameters of SHR0302: AUC0-t | Based on pre-dose, 0.25-72 hours post-dose sampling times after administration on Day1 and Day 5 | |
| PK parameters of SHR0302: AUC0-inf | Based on pre-dose, 0.25-72 hours post-dose sampling times after administration on Day 1 and Day 5 | |
| Relative bioavailability (F%) between SHR0302 sustained-release tablets and SHR0302 rapid release tablets | F%=AUC (sustained-release tablets) * dose (rapid release tablets)/AUC (rapid release tablets) * dose (sustained-release tablets) × 100% | Based on pre-dose, 0.25-72 hours post-dose sampling times after administration on Day 1 and Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of SHR0302: Tmax | 0 hour to 72 hour after administration with sustained-release tablets or rapid release tablets on Day 1 and Day 5 | |
| PK parameters of SHR0302: t1/2 | 0 hour to 72 hour after administration with sustained-release tablets or rapid release tablets on Day 1 and Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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There will be two independent cohorts of subjects who will each receive two treatments (quick release tablets and sustained-release tablets), and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability.
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| SHR0302 sustained-release tablets | Drug | SHR0302 sustained-release tablets 10 mg |
|
| PK parameters of SHR0302: CL/F | 0 hour to 72 hour after administration with sustained-release tablets or rapid release tablets on Day 1 and Day 5 |
| PK parameters of SHR0302: Vz/F | 0 hour to 72 hour after administration with sustained-release tablets or rapid release tablets on Day 1 and Day 5 |
| Adverse events of SHR0302 with sustained-release tablets or rapid release tablets | from ICF signing date to day 12 (±1) |