A Clinical Trial to Assess the Effects of Food on the Bioavailability of CKD-337

This clinical trial is to evaluate the effects of food on pharmacokinetics of CKD-337.

Sixteen male subjects are divided into two groups. A group of subjects are administered a single oral dose of CKD-337 after ingesting high fat meal and the other take same investigational product (IP) in fasting condition. Then their blood is drawn on a fixed schedule to analyse bioavailability of CKD-337.

Finishing the first treatment period, the two groups switch food conditions and initiate the second period. The group of people that were administered CKD-337 with food are then dosed the same IP in fasting condition, and the other group undergo vice versa.

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

Inclusion criteria

• Healthy male subjects between the ages of 19 and 45 years
• Body mass index between 17.5 and 30.5 kg/m², body weight more than 55kg
• Subject who doesn't have chronic disease, pathological symptoms or findings
• Subject who is suitable for the clinical trial determined by laboratory tests(serum test, hematology test, blood chemistry, urinalysis test etc.), Vital Sign, ECG test at the time of screening
• Subject who fully understand the clinical trial after in-depth explanation, decide to join the clinical trials and sign on an inform consent from willingly.

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 medical histories listed below.

• 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 drugs containing choline fenofibrate, fenofibrate or atorvastatin, or other drugs such as aspirin, fenofibrate series, antibiotics
• Subject who has 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 QRS wave in ECG) > 120msec
• Subject whose results of the clinical laboratory tests are included in the following categories

• CPK(Creatinine Phospho-Kinase) > 2x upper limit of normal range
• Liver function test (AST;Aspartate Transaminase, ALT;Alanine Transaminase, ALP;Alkaline phosphatase, Total bilirubin, γ-GT;Gamma-Glutamyl Transferase) > 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 examined by urinalysis at the time of screening
• Subject who took medicines that are known to significantly induce or inhibit drug metabolizing enzymes, including barbiturates, within 30 days prior to the first dose of medication
• Those who has experienced photoallergy or phototoxicity during treatment with fibrates or ketoprofen
• Subject who took ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 10 days prior to the first dose of medication
• Subject who took the medication involved in other clinical trials within 3 months prior to the first dose of medication
• Subject who donated whole conducted blood donation within 2 months or component blood donation or blood transfusion within 1 month prior to the first dose of medication
• Subject who drinks alcohol more than 21 units per a week (1unit=10g of pure alcohol) continuously within 6 month prior to the first dose of medication 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
• Subject who consumed food containing grapefruit within 48 hours prior to the first dose of medication or who can not stop consumption it until EOS(End of study)
• Subject who consumed food containing caffeine(e.g. coffee, green tea etc.) within 24 hours prior to the first dose of medication or who can not stop consumption it until discharge
• Subject who do not use a reliable contraception or who plans a pregnancy during the clinical trial
• Subject who has unsuitable conditions decided by investigator's judgement including clinical laboratory result