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Clinical trial to evaluate the pharmacokinetic interactions and safety between single dose of amlodipine 10mg and candesartan 32mg and the combination dose amlodipine 10mg with candesartan 32mg in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| candesartan | Experimental | Single administration : candesartan cilexetil 32mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd |
|
| amlodipine | Experimental | Single administration : amlodipine 10mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| candesartan cilexetil 32mg, amlodipine 10mg | Drug | Part A: Treatment A (candesartan), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover. Part B: Treatment A (Amlodipine), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC, Cmax | 7days, 10days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmin, tmax, CL/F | 7days, 10days |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam national university hospital, clinical trial center | Daejeon | Chungcheongbul-do | 301-721 | South Korea |
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| ID | Term |
|---|---|
| C077793 | candesartan cilexetil |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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