evaluating of pharmacokinetic profile of bcwp_c003 and co-administration of rosuvastatin and metformin

Conditions: Healthy

Summary: the purpose of this study is to evaluate the pharmacokinetic profile and safety/tolerability of bcwp_c003 compared to co-administration of crestor 10mg and glucophage xr 1000mg, and to evaluate the food effect of pharmacokinetic profile of bcwp_c003 after administration.

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.

Eligibility criteria:
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