Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate
NCT ID: NCT01845272
Last Updated: 2013-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2013-04-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Part 1
single administration : candesartan cilexetil 32mg, qd, 10days(oral).
combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral).
candesartan cilexetil 32mg, amlodipine 10mg
Treatment A (candesartan 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover
candesartan cilexetil 32mg, amlodipine 10mg
Treatment A (amlodipine 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover
Part 2
single administration : amlodipine 10mg, qd, 10days(oral).
combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral).
candesartan cilexetil 32mg, amlodipine 10mg
Treatment A (candesartan 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover
candesartan cilexetil 32mg, amlodipine 10mg
Treatment A (amlodipine 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover
Interventions
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candesartan cilexetil 32mg, amlodipine 10mg
Treatment A (candesartan 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover
candesartan cilexetil 32mg, amlodipine 10mg
Treatment A (amlodipine 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
55 Years
MALE
Yes
Sponsors
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HK inno.N Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jae-wook Ko, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Other Identifiers
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CJ_CCA_101
Identifier Type: -
Identifier Source: org_study_id
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