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This study was to evaluate the pharmacokinetics and safety of SHR6390 at doses of 100 mg, 125 mg, and 150 mg after process modification in Chinese healthy volunteers. A single oral dose of SHR6390 was given to each group, including 100 mg, 125mg and 150mg of SHR6390.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR6390(100mg) | Experimental |
| |
| SHR6390(125mg) | Experimental |
| |
| SHR6390(150mg) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR6390(100mg) | Drug | SHR6390 at a single oral dose of 100 mg. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 12 days |
| Area under the plasma concentration versus time curve (AUC)0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | 12 days |
| Area under the plasma concentration versus time curve (AUC)0-∞ | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ | 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Collection of adverse events | 22 days |
| Incidence of abnormal blood pressure | Monitor both systolic and diastolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
half male and half female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase I Clinical Research Center | Qingdao | Shandong | 266003 | China |
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| SHR6390(125mg) |
| Drug |
SHR6390 at a single oral dose of 125 mg. |
|
| SHR6390(150mg) | Drug | SHR6390 at a single oral dose of 150 mg. |
|
| 22 days |
| Incidence of abnormal temperature | Monitor the temperature | 22 days |
| Incidence of abnormal electrocardiogram waveform | Electrocardiogram inspection | 22 days |