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(Atorvastatin Calcium Trihydrate+Fenofibrate).

Each treatment period was separated by a washout period of at least 7 days.

• Inclusion Criteria:

• Healthy male older than 19 years and under 45 years at the time of screening
• BMI 17.5~30.5 kg/m² and body weight more than 55kg

• BMI = Weight(kg)/{Height(m)}²
• 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 etc.), Vital Sign, ECG test at the time of screening
• Subject who fully understand the clinical trials after in-depth explanation, decide to join the clinical trials and sign on an inform consent from willing
• Exclusion Criteria:

• Subject who has a clinically significant disease such as hepatic, kidneys, neurological, respiratory, endocrine, hemato-oncology, urinary, cardiovascular, musculoskeletal or psychiatric diseases and who has a following history

• Gallbladder disease including cholelithiasis, severe hepatic impairment
• Acute/chronic pancreatitis due to hypertriglyceridemia
• Pulmonary embolism or interstitial lung disease
• Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Hypoalbuminemia
• Alcoholics
• 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 in the EKG at the time of screening

• QTc(Q-T interval corrected for heart rate) > 450ms
• PR interval(The interval between the beginning of the P wave and the beginning of the QRS complex in ECG) > 200msec
• QRS duration(The duration of the Q,R and S wave in ECG) > 120msec
• The following results in the clinical laboratory tests

• CPK(Creatinine Phospho-Kinase) > 2 x upper limit of normal range
• Liver function test(AST; Aspartate Transaminase, ALT; Alanine Transaminase, ALP; Alkaline phosphatase, Total bilirubin, γ-GT) > 2 x upper limit of normal range
• eGFR(Estimated Glomerular Filtration Rate) < 60 mL/min/1.73m² Calculated by MDRD(Modification of Diet in Renal Disease)
• Systolic blood pressure ≥ 160mmHg(millimeter of mercury) or ≤ 100mmHg(millimeter of mercury) , Diastolic blood pressure ≥ 95mmHg(millimeter of mercury) or ≤ 60mmHg(millimeter of mercury) at the time of screening
• History of drug abuse or a positive reaction for drug abuse in the urine at the time of screening
• Taking medicines that are known to significantly induce or inhibit drug metabolizing enzymes, including barbiturates, within 30 days of the first dosing
• Those who experience photoallergy or phototoxicity during treatment with fibrates or ketoprofen
• Taking ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 10 days 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, component blood donation or blood transfusion within 1 month before the first dosing
• Alcohol > 21 units/week (1unit=10g of pure alcohol), continuously within 6 month before the first dosing or Who can not stop drinking alcohol during the clinical trial
• Smoker(> 10 cigarettes/day) for the last 3 months or who can not stop smoking during the clinical trial
• Consumption of food containing grapefruit within 48 hours before first dosing and who can not stop consumption it until EOS(End of study)
• Consumption of food containing caffeine(e.g. coffee, green tea etc.) within 24 hours before first dosing and who can not stop consumption it until discharge
• Not using a reliable contraception or planning a pregnancy during the clinical trial
• Unsuitable Conditions including laboratory result by investigator's judgement