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The purpose of the study is to evaluate the effect of kidney function on pharmacokinetics and pharmacodynamics of DWP16001 following single and multiple oral doses in type 2 diabetes patients with normal kidney function and renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP16001 Single dose | Experimental | Single dose |
|
| DWP16001 Multiple dose | Experimental | Up to 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP16001 | Drug | Tablets, Oral, Once daily, Single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration [Cmax] | on Days 1 to 4 at selected time points | |
| Concentration-time curve [AUC] | on Days 1 to 4 at selected time points | |
| Urine glucose (g/day) | Cummulative by time | on Days -1 to 4 |
| Concentration of serum glucose | on Days 1 to 4 at selected time points |
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Inclusion Criteria:
Exclusion Criteria:
Have clinically uncontrolled or unstable hepatic, neurological, immune system, respiratory, hemato-oncology, cardiovascular, or psychiatric disorder (subject with chronic disease such as hypertension, diabetes, and hyperlipidemia that is well controlled or stable is eligible to participate in the study based on investigator's judgement)
History of gastrointestinal diseases, dialysis, kidney transplantation, HIV, hepatitis B or C, acute or chronic infection, recent diabetic ketoacidosis, or gastrointestinal surgery that may affect the absorption of the study drug
Received SGLT2 inhibitors or drugs of thiazolidinedione class within 6 weeks of scheduled IP administration day
Clinical laboratory test values are outside the accepted normal range at screening
Sitting systolic blood pressure < 80 mmHg or > 180 mmHg or sitting diastolic blood pressure < 60 mmHg or > 110 mmHg after resting for more than 3 minutes
Other exclusive inclusion criteria, as defined in the protocol
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38618974 | Derived | Jeong SI, Ban MS, Hwang JG, Park MK, Lim S, Kim S, Kwon SK, Kim Y, Cho JM, Na JJ, Huh W, Chung JY. The effect of renal function on the pharmacokinetics and pharmacodynamics of enavogliflozin, a potent and selective sodium-glucose cotransporter-2 inhibitor, in type 2 diabetes. Diabetes Obes Metab. 2024 Jul;26(7):2588-2597. doi: 10.1111/dom.15573. Epub 2024 Apr 15. |
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| ID | Term |
|---|---|
| C000729921 | Enavogliflozin |
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| DWP16001 |
| Drug |
Tablets, Oral, Once daily, Multiple dose |
|