CKD-337(2) Drug-drug Interaction Study

This study is a randomized, open-label, multiple dosing, 3-way crossover design to evaluate the drug-drug interaction between Atorvastatin (Lipitor) and Fenofibric (Trilipix) acid in healthy male subjects. Subjects will receive repeated dose of Atorvastatin (40mg*1Tab/day) or Fenofibric acid (135mg*1Cap/day) or Atorvastatin (40mg*1Tab/day)/Fenofibric acid (135mg*1Cap/day). Each treatment period was separated by a washout period of at least 8 days.

Inclusion criteria

• Healthy man older than 19 years at the time of screening.
• BMI more than 17.5kg / m2 and less than 30.5kg / m2 and weight more than 55kg
• Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
• Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as ECG test.
• Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
• Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.

Exclusion criteria

• Subject who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
• Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
• Showing the value that corresponds to following laboratory parameters: AST or AST or CK > 2* upper limit of normal range.
• Alcohol > 210g/week, within 6 months prior to the screening.
• Taking the medication involved in other clinical trials within two months before the first dose medication characters.
• Sitting Systolic Blood Pressure ≥ 140 mmHg, Diastolic Blood Pressure ≥ 90 mmHg at the time of screening.
• History of alcohol or drug abuse, within 1 year
• Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
• Smoker (> 20cigarettes/day)
• Subjects who takes ETC or OTC medicine within 10days before the first IP administration.
• Subject who done the whole blood donation within two months or component blood donation within 1 month within 1 month prior to the first dosing.
• Subject who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
• Subject with serious history of hypersensitivity or allergy to investigational product.
• Active liver disease.
• Muscle disease.
• Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.
• Patients with severe hepatic impairment or Gallbladder Disease.
• Patients with moderate to severe renal impairment.
• Patients experienced allergy or phototoxicity during treatment with fibrate or ketoprofen.
• Subjects who is not able to comply with guidelines described in the protocol.
• Subjects who is determined by investigator's decision as unsuitable for clinical trial participation.