Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate

Study Overview
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Brief Summary
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This study is designated to evaluate the pharmacokinetic interactions of candesartan cilexetil and amlodipine besylate in healthy male volunteers.

Official Title
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Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate in Healthy Male Volunteers.

Conditions
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Healthy

Intervention / Treatment
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* Drug: candesartan cilexetil 32mg, amlodipine 10mg
* Drug: candesartan cilexetil 32mg, amlodipine 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male volunteers in the age between 20 and 55 years old(inclusive) Body mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive) Available for the entire study period Understand the requirements of the study and voluntarily consent to participate in the study 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 caffeine(coffee,tea,coke) or grapefruit juice > 4cups/day smoking > 20 cigarettes/day alcohol > 140g/week 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>single administration : candesartan cilexetil 32mg, qd, 10days(oral). combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral). | Drug: candesartan cilexetil 32mg, amlodipine 10mg<br>* Treatment A (candesartan 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover<br>* Other names: atacand 32mg, norvasc 10mg;Drug: candesartan cilexetil 32mg, amlodipine 10mg<br>* Treatment A (amlodipine 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover<br>* Other names: atacand 32mg, norvasc 10mg;|
| Experimental: Part 2<br>single administration : amlodipine 10mg, qd, 10days(oral). combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral). | Drug: candesartan cilexetil 32mg, amlodipine 10mg<br>* Treatment A (candesartan 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover<br>* Other names: atacand 32mg, norvasc 10mg;Drug: candesartan cilexetil 32mg, amlodipine 10mg<br>* Treatment A (amlodipine 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover<br>* Other names: atacand 32mg, norvasc 10mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the drug-drug interactions of candesartan and amlodipine |  | 10 days |