Evaluating of Pharmacokinetic Profile of BCWP_C003 and Co-administration of Rosuvastatin and Metformin

Clinical Trials to Evaluate the Pharmacokinetic Profiles and Safety/Tolerability of BCWP_C003 Formulation compared to Coadministration of Rosuvastatin and Metformin SR Formulation, and to Evaluate the Effect of Food on the Pharmacokinetic Profile of BCWP_C003 after Single Oral Administration to Healthy Male Subjects.

Inclusion criteria

• Healthy Male Volunteer, age 19 to 45 years at the time of screening
• Body weight is not less than 55kg, not more than 90kg and the result of Body Mass Index(BMI) is not less than 18.5, not more than 25.0
• Subject who has no congenital, chronic disease, and no disease symptom or finding in medical examination result
• Subject who comprehended the purpose, contents of the study, property of clinical drug and signed the informed consent to participate in the trial having the willingness

Exclusion criteria

• Subject who has history of hypersensitivity reaction for relevant drug(statin, biguanide) or clinically significant hypersensitivity reaction
• Subject who has history or presence of clinically disease in liver, kidney, gastrointestinal tract, respiratory system, musculoskeletal, endocrine system, mental disorder, blood-tumor, cardiovascular. Particulary, subject who has bleeding disorder or tend to be bleeding with bruised easily
• Subject who has family history of hereditary muscular disorder or muscular side effect
• Subject who has history of gastrointestinal tract disorder which can affect the drug absorption or surgery(excluding appendectomy, hernia surgery)
• Subject who had taken diagnosis with peptic ulcer within 2 month prior to the drug administration
• Subject who has results of clinical laboratory test as follows :

• AST, ALT level exceed the normal range more than 1.5 times
• Total bilirubin level exceed the normal range more than 1.5 times
• Creatinine clearance under 60mL/min calculated by MDRD
• In the vital sign, systolic blood pressure is more than 150mmHg, less than 90mmHg or diastolic blood pressure is more than 95mmHg, less than 50mmHg
• Subject who has presence or history of drug abuse, or positive screening for drug abuse

→ Alcohol abuse defines to drink over 21 unit/week(alcohol 1unit = 10g = 12.5 mL) persistingly

• Subject who participated in another clinical trial within 3 month prior to the drug administration
• Subject who had taken medicine(Barbital etc) related drug metabolizing enzyme induction or inhibition within 1 month prior to the drug administration
• Subject who had taken prescription drug or oriental medicine within 2 weeks or OTC drug or vitamin formulation within a week prior to the drug administration
• Subject who had a diet which can affect the absorption, distribution, metabolism or elimination of Rosuvastatin/Metformin (Particulary, Grapefruit - within 48h prior to the drug administration)
• Subject who donated whole blood within 2 month or component blood within 1 month prior to the drug administration
• Subject who smokes more than 10 cigarettes per day
• Subject who has positive HBsAg, HCV Ab or HIV Ab
• Subject who is judged to be ineligible by principal investigator or sub-investigator according to various test results