Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers

Exclusion Criteria

• •1. A subject who has medical history of or has clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrinological, neurologic, hematologic/oncologic, or cardiovascular disease
• •2. A subject with severe renal insufficiency (CrCL \< 10mL/min by Cockcroft-Gault estimation)
• •3. A subject with a history of gastrointestinal disease (e.g., ulcer, Crohn's disease) or surgery (except a simple appendectomy or repair of a hernia) that may influence the absorption of the study drug
• •4. A subject with a history of drug allergies to valsartan, rosuvastatin, or other drugs (e.g., aspirin, antibiotics), or a history of clinically significant allergies
• •5. A subject with a history of drug abuse or a positive urine drug screen for barbiturate, benzodiazepine, methamphetamine, cannabinoids, cocaine, or opiate
• •6. A subject who has taken any prescribed medication or herbal compounds within 14 days before the first drug administration. In addition, a subject who has taken any over-the-counter drug or vitamin supplement within 7 days before the first drug administration. (However, investigators made the final decision on the eligibility for the trial if all other conditions were satisfied)
• •7. A subject who has participated in any other clinical trial and received study drug within 60 days before the first drug administration
• •8. A subject who has donated a unit of blood or blood components within 60 days or 30 days, respectively, or received a transfusion before the first drug administration
• •9. A subject who has taken the drug which inhibits or induces drug metabolism such as barbital
• •10. A subject with unusual dietary habit which may influence on the administration, distribution, metabolism or excretion of drugs
• •11. A subject who consumes caffeine excessively (\> 5 units/day)
• •12. A subject with consumes alcohol excessively (\> 21 units/week, 1 unit = 10 mL of pure alcohol) or with a history of alcoholism
• •13. A heavy smoker ( \>10 cigarettes/day)
• •14. A subject of positive result in serology tests (HBV, HCV, HIV, or syphilis)
• •15. A subject who has hereditary muscle disease or family history of hereditary muscle disease, or who has history of muscle disorder induced by drug
• •16. The investigator determines whether or not the subject is eligible for the study after, for example, reviewing clinical laboratory results, ECG result, or for other reason