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The purpose of this study is to evaluate the influence of HRS9531 injection on pharmacokinetics of metformin in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 injection | Drug | HRS9531 injection single dose. |
| |
| Metformin Hydrochloride tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration versus time curve (AUC) of metformin from dosing time (0) to tau (dosing interval) (AUCtau) after 3.5 days. | Start of treatment up to 12 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (Tmax) of metformin after 3.5 days of treatment. | Start of Treatment up to 30 hours. | |
| Maximum concentration (Cmax) of metformin after 3.5 days of treatment. | Start of Treatment up to 30 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230000 | 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 |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Drug |
Metformin Hydrochloride tablets 500mg. |
|
| Area under the concentration versus time curve of metformin from 0 to the time of the last measurable (positive) concentration (AUC0-t) after 3.5 days of treatment. | Start of Treatment up to 30 hours. |
| Area under the concentration versus time curve of metformin from 0 to infinity (AUC0-inf) after 3.5 days of treatment. | Start of Treatment up to 30 hours. |
| Terminal half-life (t1/2) of metformin after 3.5 days of treatment. | Start of Treatment up to 30 hours. |
| Clearance (CL/F) of metformin after 3.5 days of treatment. | Start of Treatment up to 30 hours. |
| Apparent volume of distribution (VzF) of metformin after 3.5 days of treatment. | Start of Treatment up to 30 hours. |
| Time to maximum concentration (Tmax) of HRS9531. | Start of Treatment up to 504 hours. |
| Maximum concentration (Cmax) of HRS9531. | Start of Treatment up to 504 hours. |
| Area under the concentration versus time curve of HRS9531 from 0 to the time of the last measurable (positive) concentration (AUC0-t). | Start of Treatment up to 30 hours. |
| Area under the concentration versus time curve of HRS9531 from 0 to infinity (AUC0-inf). | Start of Treatment up to 504 hours. |
| Terminal half-life (t1/2) of HRS9531. | Start of Treatment up to 504 hours. |
| Clearance (CL/F) of HRS9531. | Start of Treatment up to 504 hours. |
| Apparent volume of distribution (VzF) of HRS9531. | Start of Treatment up to 504 hours. |
| Incidence and severity of adverse events. | Screening period up to 42 days. |
| D004700 | Endocrine System Diseases |