Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects

Study Overview
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Brief Summary
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The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin and metformin single or co-administered in healthy volunteers

Official Title
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An Open-label, Fixed-sequence Study to Evaluate Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Period I : atorvastatin, Period II : atorvastatin and metformin
* Drug: Period I : metformin, Period II : atorvastatin and metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br>single administration : atorvastatin 40mg, qd, 7days(oral) combination administration : atorvastatin 40mg and metformin XR 1000mg, qd, 7days(oral) | Drug: Period I : atorvastatin, Period II : atorvastatin and metformin<br> <br> |
| Experimental: Part B<br>single administration : metformin XR 1000mg, qd, 7days(oral) combination administration : atorvastatin 40mg and metformin XR 1000mg, qd, 7days(oral) | Drug: Period I : metformin, Period II : atorvastatin and metformin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate PK interaction of atorvastatin and metformin |  | Throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate PK interaction of 2-OH-atorvastatin and metformin |  | Throughout the study |