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This is a Randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of CKD-383 and the co-administration of CKD-501, D745, and D150 for healthy subjects in fed state
Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 or 4 tablets in single dose: actual medication)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
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| Group B | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG | Drug | At around 8 a.m., take Test drug or Reference drug 1,2,3(oral) with 200 mL of water at room temperature. |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of Lobeglitazone, Empagliflozin, Metformin | Pharmacokinetic characterization | 0 hour ~ 48 hour after drug administration |
| Cmax of Lobeglitazone, Empagliflozin, Metformin | Pharmacokinetic characterization | 0 hour ~ 48 hour after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC∞ of Lobeglitazone, Empagliflozin, Metformin | Pharmacokinetic characterization | 0 hour ~ 48 hour after drug administration |
| Tmax of Lobeglitazone, Empagliflozin, Metformin | Pharmacokinetic characterization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun Hwan Oh, PI | Chung-Ang University Gwangmyeong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Gwangmyeong Hospital | Gyeonggi-do | South Korea |
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| 0 hour ~ 48 hour after drug administration |
| T1/2 of Lobeglitazone, Empagliflozin, Metformin | Pharmacokinetic characterization | 0 hour ~ 48 hour after drug administration |
| CL/F of Lobeglitazone, Empagliflozin, Metformin | Pharmacokinetic characterization | 0 hour ~ 48 hour after drug administration |
| Vd/F of Lobeglitazone, Empagliflozin, Metformin | Pharmacokinetic characterization | 0 hour ~ 48 hour after drug administration |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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