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Compare the pharmacokinetic characteristics and safety between CKD-333 tablet and CKD-330, D086 combination
An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-333 and coadministration of CKD-330 and D086 in healthy male adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Period 1: Test drug 1(CKD-333 formulation I) Period 2: Test drug 2(CKD-333 formulation II) Period 3: Reference drug(CKD-330 + D086) |
|
| Group 2 | Experimental | Period 1: Test drug 1(CKD-333 formulation I) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 2(CKD-333 formulation II) |
|
| Group 3 | Experimental | Period 1: Test drug 2(CKD-333 formulation II) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 1(CKD-333 formulation I) |
|
| Group 4 | Experimental | Period 1: Test drug 2(CKD-333 formulation II) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Reference drug(CKD-330 + D086) |
|
| Group 5 | Experimental | Period 1: Reference drug(CKD-330 + D086) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Test drug 2(CKD-333 formulation II) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-333 formulation I | Drug | 1 tablet administered before the breakfast(single-dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCt(Area under the plasma drug concentration-time curve) PK of Candesartan, Amlodipine, Atorvastatin | 0~72hours | |
| Cmax(Maximum plasma concentration of the drug in plasma) of Candesartan, Amlodipine, Atorvastatin | 0~72hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf(Area under the plasma concentration-time curve from time t to infinity) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin | 0~72hours | |
| Tmax(Time to reach the maximum concentration) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seunghun Han, Ph.D. | Department of Clinical Pharmacology, Seoul ST.Mayr's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Saint Mary's Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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|
| Group 6 | Experimental | Period 1: Reference drug(CKD-330 + D086) Period 2: Test durg 2(CKD-333 formulation II) Period 3: Test drug 1(CKD-333 formulation I) |
|
|
| CKD-333 formulation II | Drug | 1 tablet administered before the breakfast(single-dose) |
|
|
| CKD-330+D086 | Drug | 2 tablet administered before the breakfast(single-dose) |
|
|
| 0~72hours |
| t1/2(Time for Cmax to drop in half) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin | 0~72hours |
| CL/F(Apparent clearance) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin | 0~72hours |
| Vd/F(Apparent volume of distribution) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin | 0~72hours |
| D009750 | Nutritional and Metabolic Diseases |