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The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single and multiple oral doses of 5mg to 20 mg SHR3824 in Type 2 diabetes mellitus patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort1 | Experimental | 5-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10. |
|
| Cohort2 | Experimental | 10-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10. |
|
| Cohort3 | Experimental | 20-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR3824 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetic parameters of SHR3824 | up to Day 13 | |
| Urine glucose concentration of SHR3824 | up to Day 11 | |
| Plasma glucose concentration of SHR3824 | up to Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| The number and type of adverse events reported | Up to Day 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000611095 | henagliflozin |
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| Drug |
|
| D004700 | Endocrine System Diseases |