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The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient.
This trial was a parallel, open-label, single dose study. The subject was divided into one of three groups according to the degree of renal Insufficiency,including normal, mild and moderate. All subjects were given SHR3824 20mg, the blood and urine samples were collected before and after dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal renal function | Active Comparator | All subjects were given SHR3824 20mg only one time. |
|
| Mild renal dysfunction | Active Comparator | All subjects were given SHR3824 20mg only one time. |
|
| Moderate renal dysfunction | Active Comparator | All subjects were given SHR3824 20mg only one time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR3824 | Drug | All subjects were given SHR3824 20mg only one time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The area under the plasma concentration-time curve (AUC) of SHR3824 | AUC (a measure of the body's exposure to SHR3824) will be compared between normal renal function patients and mild or moderate renal dysfunction patients | 72 hours after dosing |
| The maximum plasma concentration (Cmax) of SHR3824 | Cmax (a measure of the body's exposure to SHR3824) will be compared between normal renal function patients and mild or moderate renal dysfunction patients | 72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability | The number of volunteers with adverse events as a measure of safety and tolerability | 72 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyan Liu, Phd | Contact | +86-15705155025 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese people's liberation army general hospital of Chengdu military area | Recruiting | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000611095 | henagliflozin |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |