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The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candesartan and Amlodipine | Active Comparator | Candesartan 8mg and Amlodipine 5mg, PO, 1day or 22day |
|
| CKD-330 | Experimental | CKD-330 8/5mg, PO, 1day or 22day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan 8mg | Drug | PO, 1day or 22day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax(Maximum Plasma Concentration) of Candesartan | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr | |
| AUCt(Area Under the Plasma Concentration-time curve) of Candesartan | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr | |
| Cmax(Maximum Plasma Concentration) of Amlodipine | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr | |
| AUCt(Area Under the Plasma Concentration-time curve) of Amlodipine | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf(Area Under the Plasma Concentration-time curve from time t to infinity) of Candesartan | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr | |
| tmax(Time to reach the maximum concentration) of Candesartan | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jang Hee Hong, MD, PhD | Chungnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | Jung-gu | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C081643 | candesartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Amlodipine 5mg |
| Drug |
PO, 1day or 22day |
|
| CKD-330 8/5mg | Drug | PO, 1day or 22day |
|
| t1/2β(Time for C max to drop in half) of Candesartan | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr |
| CL/F(Clearance/Bioavailability) of Candesartan | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr |
| AUCinf(Area Under the Plasma Concentration-time curve from time t to infinity) of Amlodipine | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
| tmax(Time to reach the maximum concentration) of Amlodipine | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
| t1/2β(Time for C max to drop in half) of Amlodipine | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
| CL/F(Clearance/Bioavailability) of Amlodipine | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |