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SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this multiple-dose study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort SHR3824/Placebo 1.25 mg | Experimental | SHR3824 1.25 mg/day or placebo for 10 days. |
|
| Cohort SHR3824/Placebo 2.5 mg | Experimental | SHR3824 2.5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort. |
|
| Cohort SHR3824/Placebo 5 mg | Experimental | SHR3824 5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort. |
|
| Cohort SHR3824/Placebo 10 mg | Experimental | SHR3824 10 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort. |
|
| Cohort SHR3824/Placebo 25 mg | Experimental | SHR3824 25 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR3824 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC(Area under the curve) of SHR3824. | day1 and day11 to day 13. | |
| Cmax(the maximum concentration) of SHR3824. | day1 and day11 to day 13. | |
| Tmax(the time reaching maximum concentration) of SHR3824. | day1 and day11 to day 13. | |
| Halflife of SHR3824. | day1 and day11 to day 13. | |
| CL/F of SHR3824. | day1 and day11 to day 13. | |
| V/F of SHR3824. | day1 and day11 to day 13. | |
| Accumulation ratio of SHR3824 | Up to day 13. | |
| Urine glucose concentration of SHR3824. | day1 and day11 | |
| Plasma glucose concentration of SHR3824. | day1 and day11 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, vital signs, physical exams , ECG, clinical labs | Days -14 to -1, 0, 13. | |
| Serum creatinine | Days -14 to -1, 0, 2, 9, 13. |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200030 | China |
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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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| Cohort SHR3824/Placebo 100mg | Experimental | SHR3824 100 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort. |
|
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| Placebo | Drug |
|
| D004700 | Endocrine System Diseases |