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The purpose of this study is to evaluate the relative bioavailability of the new formulation of HRS9531 injection between the original formulation of HRS9531 injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R group (reference formulation group) | Experimental |
| |
| T group (test formulation group) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 | Drug | Receive a single dose of HRS9531 of original formulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration versus time curve (AUC) of HRS953 | Start of treatment up to Day 43 | |
| Maximum Concentration (Cmax) of HRS9531 | Start of Treatment up to Day 43 | |
| Calculate the ratio of bioavailability between the new formulation and original formulation of HRS9531 according to the equation F (relative bioavailability) =AUCT·DR/AUCR·DT×100% | Start of Treatment up to Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (Tmax) | Start of Treatment up to Day 43 | |
| Apparent terminal half-life (t1/2) | Start of Treatment up to Day 43 | |
| Clearance (CL/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central hospital affiliated to Shandong first mecical university | Jinan | Shandong | 250014 | 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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This study is a single-dose, parallel design trial, consisting of two parallel groups: a reference formulation group (R: original formulation) and a test formulation group (T: new formulation). Both R and T groups receive a same dose of HRS9531.
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| HRS9531 | Drug | Receive a single dose of HRS9531 of new formulation. |
|
| Start of Treatment up to Day 43 |
| Apparent volume of distribution (VzF) | Start of Treatment up to Day 43 |
| Incidence and severity of adverse events | Screening period up to Day 43 |
| D004700 | Endocrine System Diseases |