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This is a randomized, placebo-controlled, multiple dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with dose of 5 mg, 10mg and 25 mg. Chinese Type 2 Diabetic patients will be randomized in each cohort to receive the study drug or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Twelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 5 mg SHR0534 or matching placebo. |
|
| Cohort 2 | Experimental | Twelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 10 mg SHR0534 or matching placebo. |
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| Cohort 3 | Experimental | Twelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 25 mg SHR0534 or matching placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0534 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events | From baseline up to 8 days after last treatment (Day 38) | |
| Area under the plasma concentration curve after the first and last multiple oral dose (AUC) | From time 0 to 24 hours for the first dose, and from time 0 to 192 hours after the last dose | |
| Peak plasma concentration (Cmax) after the first and last multiple oral dose | From time 0 to 24 hours for the first dose, and from time 0 to 192 hours after the last dose | |
| Terminal elimination halflife (t½) for SHR0534 after the last multiple oral dose | From time 0 to 192 hours after the last dose | |
| Changes in the concentrations of blood glucose and insulin after multiple oral dose | From baseline up to 24 hours after last treatment (Day 31)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| ID | Term |
|---|---|
| C000715114 | SHR0534 |
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