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The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of Candesartan between free combination of Candesartan and Amlodipine and Candesartan monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C(Candesartan 32mg) | Experimental | Candesartan 32mg 1T, PO, QD for 9days |
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| B(Candesartan 32mg/Amlodipine 10mg) | Experimental | Candesartan 32mg 1T, PO, QD for 9days/Amlodipine 10mg 1T, PO, QD for 9days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan 32mg | Drug | Candesartan 32mg 1T, PO, QD for 9days |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss of Candesartan | 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 10D 0h, 11D 0h | |
| Cmax,ss of Candesartan | 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 10D 0h, 11D 0h |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax,ss of Candesartan | 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 10D 0h, 11D 0h |
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Inclusion Criteria:
Healthy male volunteer is between 20 and 45 years of age(inclusive) at the pre-study(screening).
Volunteer who has 19kg/m² ≤ BMI(Body Mass Index) ≤ 26kg/m²
When volunteer in screening, Must include under the items.
Those who decided to join the clinical trials by themselves and to comply with the precautions written consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyun-Seop Bae, Professor | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Songpa-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 |
| C077793 | candesartan cilexetil |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Candesartan 32mg/Amlodipine 10mg | Drug | Candesartan 32mg 1T, PO, QD for 9days/Amlodipine 10mg 1T, PO, QD for 9days |
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