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To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in type 2 diabetic subjects with normal renal function and mild to moderate renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A and C (normal kidney function) | Active Comparator | Each subject will receive a single dose of rongliflozin on Day 1 |
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| Group B (mild renal impairment) | Experimental | Each subject will receive a single dose of rongliflozin on Day 1 |
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| Group D (moderate renal impairment) | Experimental | Each subject will receive a single dose of rongliflozin on Day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pyroglutamate rongliflozin capsules | Drug | Subjects will receive one 50mg capsule orally (by mouth) on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of rongliflozin | Plasma concentrations of rongliflizin following the administration of a single dose of rongliflozin, the pharmacokinetic parameters for rongliflozin will be measured in varying degrees of kidney function. | 0 hour(pre-dose) to 96 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function | Change from baseline in 24-hour urine glucose excretion following the administration of a single dose of rongliflozin will be used to evaluate the pharmacodynamics of rongliflozin (ie, how the drug affects the body) in varying degrees of kidney function. | Day -1 (Baseline) to Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ping Feng, Doctor | West China Hospital | Principal Investigator |
| Zhenmei An, Master | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ping Feng | Chengdu | Sichuan | 610041 | 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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| D004700 | Endocrine System Diseases |