Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate
This trial is active, not recruiting.
|Treatments||candesartan cilexetil 32mg, amlodipine 10mg|
|Sponsor||CJ HealthCare Corporation|
|Start date||April 2013|
|End date||July 2013|
|Trial size||40 participants|
|Trial identifier||NCT01845272, CJ_CCA_101|
This study is designated to evaluate the pharmacokinetic interactions of candesartan cilexetil and amlodipine besylate in healthy male volunteers.
|Endpoint classification||pharmacokinetics study|
|Intervention model||crossover assignment|
|Primary purpose||basic science|
Assessment of the drug-drug interactions of candesartan and amlodipine
time frame: 10 days
Male participants from 20 years up to 55 years old.
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
|Official title||Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate in Healthy Male Volunteers.|
|Principal investigator||Jae-wook Ko, MD, PhD|
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