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About
This study is a randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety and pharmacokinetics of CKD-337 in healthy male volunteers.
Full description
This study is a randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety and pharmacokinetics of CKD-337 in healthy male volunteers.
Subjects will receive either a single oral dose of the test formulation(CKD-337) or a oral dose of the reference formulation(Lipitor+Lipidil supra).
Each treatment period was separated by a washout period of at least 7 days.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Subject who has a history of hepatic, kidneys, neurological, respiratory, endocrine, hemato-oncology, urinary, cardiovascular, musculoskeletal or psychiatric diseases that is clinically significant and who has a following history 1) Gallbladder disease including cholelithiasis, severe hepatic impairment 2) Acute/chronic pancreatitis due to hypertriglyceridemia 3) Pulmonary embolism or interstitial lung disease 4) Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption 5) Hypoalbuminemia 6) Alcoholics 7) Predisposition to rhabdomyolysis
Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption
Subject who has hypersensitivity to the drug composition containing choline fenofibrate, fenofibrate or atorvastatin, and other drug(aspirin, fenofibrate series, antibiotic and so on)
The following clinical significant findings at the time of screening
The following results in the clinical laboratory tests
Systolic blood pressure ≥ 160mmHg or ≤ 100mmHg, Diastolic blood pressure ≥ 95mmHg or ≤ 60mmHg at the time of screening
History of drug abuse or a positive reaction for drug abuse at the screening test for urine
Taking ETC, oriental medicine within 2 weeks and OTC, vitamin within 1 week before the first dosing
Taking the medication involved in other clinical trials within 3 months before the first dosing
Whole blood donation with 2 months or component blood donation within 1 month or blood transfusion within 1 month before the first dosing
Alcohol > 21 units/week (1unit=10g of pure alcohol), within 6 month before the first dosing
Smoker(> 10 cigarettes/day) for the last 3 months
Comsumption of grapefruit of food containing grapefruit during clinical trial period from first dosing 48hours ago
Comsumption of food containing caffeine(e.g. coffee, green tea) during 24 hours ago IP dosing at discharge
Not using a reliable contraception, planning a pregnancy during the study
An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Primary purpose
Allocation
Interventional model
Masking
48 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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