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This study is designated to evaluate the pharmacokinetic interactions of candesartan cilexetil and amlodipine besylate in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | single administration : candesartan cilexetil 32mg, qd, 10days(oral). combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral). |
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| Part 2 | Experimental | single administration : amlodipine 10mg, qd, 10days(oral). combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| candesartan cilexetil 32mg, amlodipine 10mg | Drug | Treatment A (candesartan 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the drug-drug interactions of candesartan and amlodipine | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
Systolic blood pressure outside the range of 100 to 150 mmHg or diastolic blood pressure outside the range of 60 to 1000 mmHg for male subjects. when screening period
Subject with symptoms of acute disease within 14days prior to study medication dosing
Subjects with a history of clinically significant allergies
Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT >1.5 times to normal range or total bilirubin > 1.5times to normal range)
History of drug abuse
History of caffeine, alcohol, smoking abuse
Positive test results for HBs Ab, HCV Ab, Syphilis regain test
Participation in any clinical investigation within 30days prior to study medication dosing
Subjects with whole blood donation within 60days, component blood donation within 30days and blood transfusion within 30days prior to study medication dosing
Subjects considered as unsuitable based on medical judgement by investigators
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| Name | Affiliation | Role |
|---|---|---|
| Jae-wook Ko, MD, PhD | Samsung Medical Center | Principal Investigator |
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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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| candesartan cilexetil 32mg, amlodipine 10mg | Drug | Treatment A (amlodipine 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover |
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