Healthy
Conditions
Brief summary
This study is designated to evaluate the pharmacokinetic interactions of candesartan cilexetil and amlodipine besylate in healthy male volunteers.
Interventions
Treatment A (candesartan 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the drug-drug interactions of candesartan and amlodipine | 10 days |
Outcome results
None listed