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

Study Overview
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Brief Summary
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This study evaluate the food effect on pharmacokinetics and safety of fixed-dose combination of CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg) in healthy male subjects

Conditions
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Food Effect Study of CJ-30056 20mg/500mg

Intervention / Treatment
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* Dietary Supplement: CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)


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 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CJ-30056 20mg/500mg<br>fasting, fed | Dietary Supplement: CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)<br> <br> |
| Experimental: group 2<br>fed, fasting | Dietary Supplement: CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) of atorvastatin |  | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose | 
| Peak plasma concentration (Cmax) of metformin |  | 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose | 
| area under the plasma concentration versus time curve (AUC0-t) of atorvastatin |  | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose | 
| area under the plasma concentration versus time curve (AUC0-t) of metformin |  | 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) of 2-OH-atorvastatin |  | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose | 
| Vz/F of atorvastatin and metformin |  | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose | 
| area under the plasma concentration versus time curve (AUC0-t) of 2-OH-atorvastatin |  | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose | 
| AUCinf of Atorvastatin, 2-OH-atorvastatin and metformin |  | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose | 
| Tmax of Atorvastatin, 2-OH-atorvastatin and metformin |  | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose | 
| t1/2β of Atorvastatin, 2-OH-atorvastatin and metformin |  | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose | 
| CL/F of atorvastatin and metformin |  | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose |