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Objective
- Evaluation of the pharmacokinetic properties and safety of CKD-393 0.25/50/750 mg oral administration in healthy adults under fed condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Period 1 - A single dose of 4 tablets(CKD-501 1T, D759 1T, H053 2T) under fed condition. Period 2 - A single dose of 2 tablets(CKD-393 2T) under fed condition. |
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| 2 | Experimental | Period 1 - A single dose of 2 tablets(CKD-393 2T) under fed condition. Period 2 - A single dose of 4 tablets(CKD-501 1T, D759 1T, H053 2T) under fed condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-393 | Drug | QD, PO |
| |
| CKD-501, D759, H053 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of CKD-501, D759, H053 | AUCt: Area under the concentration-time curve from time zero to time | Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hour |
| Cmax of CKD-501, D759, H053 | Cmax: Maximum plasma concentration of the drug | Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hour |
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Inclusion Criteria:
Exclusion Criteria:
Those who have clinically significant disease or medical history of heart failure, Hepatopathy, Type 1 Diabetes, Diabetic ketoacidosis, Edema, Renal dysfunction, galactose intolerance, glucose-galactose malabsorption. And Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) during clinical trial.
Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of investigational drug.
Those who have the test results written below
Those who exceeding an alcohol consumption criteria(210g/week) within 6 months before the first administration of investigational drug.
Those who exceeding smoking criteria(20 cigarettes/day) within 6 months before the first administration of investigational drug.
Those who received investigational durg by participating in other clinical trial within 6 months before the first administration of investigational drug.
Those who have vital sign written below
Those who have a drug or alcohol abuse history within 1 year before the first administration of investigational drug.
Those who take barbiturate and related (causing induction or inhibition. of metabolism) drug within 30 days before the first administration of investigational drug.
Those who received Ethical-the-counter (ETC) drugs or Over-the-counter (OTC) drugs within 10 days before the first administration of investigational drug.
Those who donated whole blood within 2 months or apheresis within 1 month before the first administration of investigational drug.
Those who severe acute/chronic medical or mental condition which can increase the safety risk by administration of investigational drug.
Those who have history of hypersensitivity to active pharmaceutical ingredient or additives.
Those who are pregnant or breastfeeding.
Those who can't ingest a high fat diet.
Those who are deemed inappropriate to participate in clinical trial by investigators.
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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 |
|---|---|
| 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 |
|---|---|
| C546215 | lobeglitazone |
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| Drug |
QD, PO |
|
| D004700 | Endocrine System Diseases |