A Clinical Trial to Compare Safety and Pharmacokinetic Characteristics of CKD-337

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.

Inclusion criteria

• Healthy male older than 19 years at the time of screening
• BMI 17.5~30.5 kg/m2 and body weight more than 55kg
• Subject who is no chronic disease, no symptoms or pathological findings
• Suitable subject who is determined by laboratory tests(hematology test, blood chemistry, urinalysis test) according to the characteristics of the drug and ECG test at the time of screening
• Subject who fully understand the clinical trials after in-depth explanation, decided to join the clinical trials by their will and signed inform consent

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

• QTc > 450ms
• PR interval > 200msec
• QRS duration > 120msec
• The following results in the clinical laboratory tests

• CPK > 2 x upper limit of normal range
• Liver function test (AST, ALT, ALP, Total bilirubin, γ-GT) > 2 x upper limit of normal range
• eGFR(estimated GFR) < 60 mL/min/1.73m2
• 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