Pharmacokinetic Drug Interaction Between Rosuvastatin and Valsartan

Exclusion Criteria

• •Have history of cardiovascular disorder(congestive heart failure, complications of coronary artery stenosis stroke and etc.), respiratory disorder, renal disorder(severe renal failure and etc.), liver disorder(moderate or severe liver failure and etc.) endocrine system disorder(diabetics, impaired glucose tolerance and etc.), digestive system disorder, central nervous system disorder, mental illness or malignant tumor
• •Have history of gastrointestinal disease(Crohn's disease, ulcer and etc.), gastrointestinal surgery(simple appendectomy or herniotomy excluded) that can affect the absorption of the drug
• •Have suffered from a clinically significant disease within 30 days prior to the first administration
• •Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with rosuvastatin or valsartan, or other drug(aspirin, antibiotics and etc.)
• •Have genetic myopathy, family history of myopathy, or history of myopathy to drugs
• •Have systolic blood pressure higher than 150mmHg or lower than 90mmHg, or diastolic blood pressure higher than 100mmHg or lower than 60mmHg, or pulse rate more than 100times/min or less than 40times/min
• •Have history of drug abuse or shown positive on drug abuse during drug screening test
• •Participated in any other clinical trials within 90 days prior to the first administration
• •Have used any herbal medicine, prescription drug, or generic medicine within 30 days, 14 days or 7 days prior to the first administration, respectively (provided, however, if other conditions are judged to be eligible by investigators, subjects can participate in the trial)
• •Donated whole blood or blood component within 60 days or 30 days prior to the first administration, respectively, or received transfusion within 30 days prior to the first administration
• •Excessive alcohol drinker(\> 140g/week; 1 glass of 12° wine(125mL) = 12.0g, 1 glass of 4° beer(250mL) = 8g, 0.5 bottle of soju(180mL) = 28.8g)
• •Heavy smoker(\> 20 cigarettes/day)
• •Excessive caffeine drinker(\> 4 cups/day)
• •Shown positive on serum test(HBsAg, HCV Ab, HIV Ab tests)
• •Subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons including their abnormal values in clinical laboratory test
• •Continuous increase of liver enzyme level(AST, ALT) of unknown cause or active liver disorder patients with liver enzyme level increasing more than 3 time of normal upper limit
• •Severe renal disorder patients(with creatinine clearance (Cr) \< 10mL/min when calculated with Modification of Diet in Renal Disease method)