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This study is a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.25/750 mg in healthy male volunteers.
To healthy male subjects of twenty six(26), following treatments are administered dosing in each period fed condition(high fat meals) and wash-out period is a minimum of 7 days.
Treatment A(Reference Drug): DuvieTM Tab. 0.5mg 1T + Glucodaun OR Tab. 750mg 2T Treatment B(Test Drug): CKD-395 0.25/750mg Tab. 2T Pharmacokinetic blood samples are collected up to 48hrs. Safety and pharmacokinetic are assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT group | Experimental | R: Reference drug(Duvie Tab. 0.5mg 1T, Glucodaun OR Tab. 750mg 2T) T: Test drug(CKD-395 0.25/750 mg 2T) |
|
| TR group | Experimental | T: Test drug(CKD-395 0.25/750 mg 2T) R: Reference drug(Duvie Tab. 0.5mg 1T, Glucodaun OR Tab. 750mg 2T) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg | Drug | oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of Lobeglitazone | Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs | |
| AUClast of metformin | Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs | |
| Cmax of Lobeglitazone | Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs | |
| Cmax of Lobeglitazone Metformin | Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of Lobeglitazone | Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs | |
| AUCinf of Metformin | Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | Jeollabuk-do | South Korea |
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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 |
|---|---|
| D013607 | Tablets |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D001645 | Biguanides |
| D006146 | Guanidines |
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| CKD-395 0.25/750mg | Drug | oral administration |
|
|
| Tmax of Lobeglitazone | Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs |
| Tmax of Metformin | Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs |
| t1/2 of Lobeglitazone | Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs |
| t1/2 of Metformin | Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs |
| CL/F of Lobeglitazone | Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs |
| CL/F of Metformin | Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs |
| Vd/F of Lobeglitazone | Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs |
| Vd/F of Metformin | Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs |
| D004700 | Endocrine System Diseases |
| D000578 |
| Amidines |
| D009930 | Organic Chemicals |