Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects

Inclusion criteria

• Willing to adhere to protocol requirements and sign a informed consent form
• Healthy male volunteers who are in age range of 20-55 years and the weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9
• 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 for this trial by investigators

Exclusion criteria

• Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
• Subjects with Symptoms of acute disease within 28days prior to study medication dosing
• Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
• Subjects with a history of abdominal surgery within food and water limit
• Subjects with a history of clinically significant allergies including drug allergies
• Subjects with anaphylaxis to atorvastatin and/or metformin
• Subjects with a history or plan iodine radiotherapy within 28 days prior to drug administration
• Subjects with a history of myopathy
• Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• 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
• Creatinine clearance <90 mL/min
• Subjects with a history of drug, caffeine and alcohol abuse(caffeine > 5cups/day, cigarette > 10/day, alcohol > 30g/day) or have ever drank 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
• Subjects who have received any drugs that might confound the results of the trial based on medical judgement by investigators within 10days prior to drug administration
• Subjects considered as unsuitable based on medical judgement by investigators