The Food Effect on Pharmacokinetics and Safety of Fixed-dose Combination of CJ-30056 in Healthy Male Subjects

Inclusion criteria

• Willing to adhere to protocol requirements and sign a informed consent form
• Male volunteers in the age between 20 and 45 years old and have the weight range is not exceed ±20% of ideal weight
• Subjects with no history of any significant chronic disease
• Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data

Exclusion criteria

• Use of barbital inducer or inhibitor medication within the 4 weeks before dosing
• Symptom of an acute illness within 4 weeks prior to drug administration
• History of clinically significant hepatic, renal, gastrointestinal diseases which might significantly interfere with ADME
• History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
• History of clinically significant allergies including drug allergies
• History of clinically significant allergies about atorvastatin or metformin
• Subjects who have ever or have plan to do intravenous injection of contrast medium (intravenous urography, intravenous cholangiography, computed tomography using contrast medium) within 28 days prior to drug administration
• History of myopathy
• Clinical laboratory test values are outside the accepted normal range

• AST or ALT >1.25 times to normal range
• Total bilirubin >1.5 times to normal range
• e-GFR <90 mL/min
• History of drug, caffein(caffein > 5 cups/day), smoking (cigarette > 10/day) or alcohol abuse(alcohol > 30 g/day)or Subjects who have ever drink within 7 days prior to drug administration
• Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
• Donated blood within 60 days prior to dosing
• Participated in a previous clinical trial within 60 days prior to dosing
• Use of any other medication, including herbal products, within 10 days before dosing
• Subjects considered as unsuitable based on medical judgement by investigators