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The purpose of this study is to compare the pharmacodynamic profile of a single subcutaneous dose of SHR-3167 injection versus insulin glargine U100 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin glargine followed by SHR-3167 injection | Experimental | Participants will receive a single injection of glargine in the Glargine period and then washout. After that, participants will receive a single injection of SHR-3167 in the SHR-3167 period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-3167 injectionï¼›glargine insulin | Drug | Drug: SHR-3167 injection Participants will receive a single subcutaneous (s.c.) injections of SHR-3167 injection Drug: glargine insulin Participants will receive a single subcutaneous (s.c.) injections of glargine insulin |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose infusion rate (GIR) - area under the curve (AUC) | Glargine period: 0-24hour ; SHR-3167 period: 0-226hour |
| Measure | Description | Time Frame |
|---|---|---|
| area under the curve (AUC0-t, AUC0-∞) | 0-1680 hour | |
| maximum concentration (Cmax) | 0-1680 hour | |
| time to reach maximum concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bishan Hospital of Chongqing | Chongqing | Chongqing Municipality | 400000 | China |
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| 0-1680 hour |
| half-life (t1/2) | 0-1680 hour |
| apparent clearance (CL/F) | 0-1680 hour |
| apparent volume of distribution (Vz/F). | 0-1680 hour |
| Change in fasting blood glucose from baseline. | 0-1680 hour |
| Hypoglycemic events | 0-1680 hour |
| adverse events (AE) | 0-1680 hour |
| Change in fasting C-peptide from baseline | 0-1680 hour |