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The object of clinical trial is to investigate the pharmacokinetics and safety compared to CKD-333 and co-administration CKD-330, D090 under fasting condition in healthy male adults.
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 D090 in healthy male adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
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| Group 2 | Experimental |
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| Group 3 | Experimental |
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| Group 4 | Experimental |
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| Group 5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-333, formula I | Drug | Test drug |
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| Measure | Description | Time Frame |
|---|---|---|
| AUClast of Candesartan | Area under the plasma concentration-time curve to last concentration of Candesartan | 0 hour ~ 72 hour after drug administration |
| AUClast of Amlodipine | Area under the plasma concentration-time curve to last concentration of Amlodipine | 0 hour ~ 72 hour after drug administration |
| AUClast of Atorvastatin | Area under the plasma concentration-time curve to last concentration of Atorvastatin | 0 hour ~ 72 hour after drug administration |
| Cmax of Candesartan | Maximum plasma concentration of Candesartan | 0 hour ~ 72 hour after drug administration |
| Cmax of Amlodipine | Maximum plasma concentration of Amlodipine | 0 hour ~ 72 hour after drug administration |
| Cmax of Atorvastatin | Maximum plasma concentration of Atorvastatin | 0 hour ~ 72 hour after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of Candesartan | Area under the plasma concentration-time curve from zero to infinity concentration of Candesartan | 0 hour ~ 72 hour after drug administration |
| AUCinf of Amlodipine | Area under the plasma concentration-time curve from zero to infinity concentration of Amlodipine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seunghun Han, Ph.D. | Contact | +82-2-2258-7326 | waystolove@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Seunghun Han, Ph.D. | Department of Clinical Pharmacology, Seoul ST.Mary'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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| Group 6 | Experimental |
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| CKD-333, formula II | Drug | Test drug |
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| CKD-330, D090 | Drug | Reference Drug |
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| 0 hour ~ 72 hour after drug administration |
| AUCinf of Atorvastatin | Area under the plasma concentration-time curve from zero to infinity concentration of Atorvastatin | 0 hour ~ 72 hour after drug administration |
| AUCinf of 2-hydroxy atorvastatin | Area under the plasma concentration-time curve from zero to infinity concentration of 2-hydroxy atorvastatin | 0 hour ~ 72 hour after drug administration |
| Tmax of Candesartan | Time to maximum plasma concentration of Candesartan | 0 hour ~ 72 hour after drug administration |
| Tmax of Amlodipine | Time to maximum plasma concentration of Amlodipine | 0 hour ~ 72 hour after drug administration |
| Tmax of Atorvastatin | Time to maximum plasma concentration of Atorvastatin | 0 hour ~ 72 hour after drug administration |
| Tmax of 2-hydroxy atorvastatin | Time to maximum plasma concentration of 2-hydroxy atorvastatin | 0 hour ~ 72 hour after drug administration |
| T1/2 of Candesartan | Half-life of Candesartan | 0 hour ~ 72 hour after drug administration |
| T1/2 of Amlodipine | Half-life of Amlodipine | 0 hour ~ 72 hour after drug administration |
| T1/2 of Atorvastatin | Half-life of Atorvastatin | 0 hour ~ 72 hour after drug administration |
| T1/2 of 2-hydroxy atorvastatin | Half-life of 2-hydroxy atorvastatin | 0 hour ~ 72 hour after drug administration |
| clearance of Candesartan | Apparent clearance of Candesartan | 0 hour ~ 72 hour after drug administration |
| clearance of Amlodipine | Apparent clearance of Amlodipine | 0 hour ~ 72 hour after drug administration |
| clearance of Atorvastatin | Apparent clearance of Atorvastatin | 0 hour ~ 72 hour after drug administration |
| clearance of 2-hydroxy atorvastatin | Apparent clearance of 2-hydroxy atorvastatin | 0 hour ~ 72 hour after drug administration |
| Vd/F of Candesartan | Apparent volume of distribution of Candesartan | 0 hour ~ 72 hour after drug administration |
| Vd/F of Amlodipine | Apparent volume of distribution of Amlodipine | 0 hour ~ 72 hour after drug administration |
| Vd/F of Atorvastatin | Apparent volume of distribution of Atorvastatin | 0 hour ~ 72 hour after drug administration |
| Vd/F of 2-hydroxy atorvastatin | Apparent volume of distribution of 2-hydroxy atorvastatin | 0 hour ~ 72 hour after drug administration |
| D009750 | Nutritional and Metabolic Diseases |