Clinical Trial to Investigate the Pharmacokinetics Drug Interaction Between Metformin and Rosuvastatin

An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Following Coadministration of Metformin and Rosuvastatin in Healthy Male Volunteers

The purpose of this study is to investigate the pharmacokinetic drug interaction between Metformin and Rosuvastatin in healthy male volunteers.

Drug-drug Interaction Following Co-administration of Metformin and Rosuvastatin in Healthy Male Volunteers

Inclusion Criteria:

• 19~55 years healthy male
• BMI measurement 19.0kg/m^2~ 28.0kg/m^2
• Signed informed consent form from to participate voluntarily and to comply with the trial requirements.

Exclusion Criteria:

• History of clinically significant kidney, liver, gastro-intestinal system, cardiovascular system, respiratory system, tumor or blood disorders, nervous system, immune system, endocrine disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
• SBP>140mmHg or <90mmHg, DBP>90mmHg or <60mmHg.
• An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
• History of drug abuse
• A alcohol consumer(alcohol>140g/week) or smoker(cigarette>10 cigarettes/day) Hypersensitivity reaction in history of investigational drugs or specific drugs(aspirin, antibiotics)
• Administrated investigational product in a previous clinical trial within 60 days of the screening day in this study.
• Administrated drugs which can inhibit or induce OCT2, OATP1B1 transporter within 30 days of the screening day in this study.(ex: proton pump inhibitor, rifampicin)
• Glomerular filtration rate<60mL/min
• Donated blood within 60 days prior to the screening day or apheresis blood within 30 days prior to the screening day .