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A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-393(2) in healthy volunteers under fed conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sequence 1 | Experimental | Period 1- A single dose of 4 tablets(CKD-501 1T, D759 1T, D150 1T, D029 1T) under fed condition Period 2- A single dose of 2 tablets(CKD-393(2) 2T) under fed condition |
|
| sequence 2 | Experimental | Period 1- A single dose of 2 tablets(CKD-393(2) 2T) under fed condition Period 2- A single dose of 4 tablets(CKD-501 1T, D759 1T, D150 1T, D029 1T) under fed condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-393(2) | Drug | QD, PO |
| |
| CKD-501, D759, D150, D029 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt | Area under the concentration-time curve from time zero to time | Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours |
| Cmax | Maximum plasma concentration of the drug | Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Gul Kim, M.D, Ph.D. | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | South Korea |
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| ID | Term |
|---|---|
| C546215 | lobeglitazone |
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| Drug |
QD, PO |
|