Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate in Healthy Male Volunteers.
Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate in Healthy Male Volunteers.
This study is designated to evaluate the pharmacokinetic interactions of candesartan cilexetil and amlodipine besylate in healthy male volunteers.
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