CKD-337 Drug Interaction Study

Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Fenofibrate and Atorvastatin in Healthy Male Volunteers

The purpose of this study is to evaluate a pharmacokinetic drug interaction between atorvastatin and fenofibrate in healthy subjects.

Inclusion Criteria:

• A healthy male volunteer between 19 and 55 years old.
• BMI between 18.5 and 27.
• Able to participate in the entire trial
• Signed the informed consent form prior to study participation.

Exclusion Criteria:

• Clinically significant digestive system, cardiovascular system, respiratory system, endocrine system, hepatic system, renal system
• sit SBP < 100mmHg or sit SBP ≥ 150mmHg or sit DBP < 70mmHg or sit DBP ≥ 100mmHg
• Have acute infection history within 14 days
• Have a allergic disease of need to treat
• Have hypersensitivity reactions history for IP or any specific drugs.
• AST, ALT or Total bilirubin > UNL * 1.5
• Estimated GFR < 60 ml/min
• Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• A heavy smoker (cigarette > 10 cigarettes per day)
• A heavy alcohol consumer (alcohol > 140g/week)
• A heavy grapefruit consumer (more than 1cup per a day)
• Have a history of drug abuse or showed a positive for urine drug test.
• Administrated IP within 60 days prior to screening
• Rhabdomyolysis include of having a history or family history of genetic muscle diseases
• Positive for HIV antibody, HBsAg, HCV antibody test
• Previously donate whole blood within 60 days or component blood within 30 days
• Subject takes ethical drug or herbal medicine within 30 days
• Clinically significant laboratory test result
• An impossible one who participates in clinical trial by investigator's decision including other reason