Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects
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ClinicalTrials.gov Identifier: NCT02609711
Recruitment Status : Unknown
Verified November 2015 by Ahn-Gook Pharmaceuticals Co.,Ltd. Recruitment status was: Active, not recruiting
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Layout table for eligibility information
Ages Eligible for Study:
19 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult healthy males 20 to 45 years at screening.
BMI 18-29 kg/m2
History of cardiovascular, respiratory, hepatic, renal, neuropsychiatric, endocrine, hematologic disease
Hypersensitivity reactions to drugs or significant hypersensitivity reactions in the history of Candesartan and Atorvastatin
Hypotension (DBP ≤ 100 mmHg or SBP ≤ 95mmHg) and hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg)
Gastrointestinal disease affected the absorption of medications
Genetic disease of Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
AST or ALT > 2 x normal range
Total bilirubin > 2.0 mg/dl
CK > 2 x normal range
eGFR < 60 mL/min/1.73m2
Subject who have drunken habitually (alcohol more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or who are unable to quit drinking during this study
Subject who have smoke habitually more than 10 cigarettes/day or who are unable to quit smoking during this study
Subject who treated with any investigational drugs within 90 days before the administration of investigational drug
Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
Subject who treated with any drug within 30 days can affect absorption, distribution, metabolism, excretion of candesartan or atorvastatin
Subject who treated with any Rx only drug or herbal drug within 14 days and any OTC within 7 days
History of drug abuse
Genetic neuromuscular disorder or family history of neuromuscular disorder
Unusual diet affected the absorption, distribution, metabolism, excretion of medications
Subjects deemed ineligible by investigator based on other reasons