Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR

Study Overview
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Brief Summary
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This study is designed to evaluate safety and pharmacokinetic properties of the two treatments, the administration of CJ-30056 and the co-administration of atorvastatin and metformin XR, in healthy volunteers.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Atorvastatin 20mg and Metformin XR 500mg (Reference)
* Drug: CJ-30056 20/500mg (Test)


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 19 and 55 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: 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Single-dose crossover Reference: Atorvastatin 20mg and Metformin XR 500mg Test: CJ-30056 20/500mg Once daily Oral administration with 7days of washout period | Drug: Atorvastatin 20mg and Metformin XR 500mg (Reference)<br>* Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between. Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.<br>Drug: CJ-30056 20/500mg (Test)<br>* Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between. Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.<br>|
| Experimental: Group 2<br>Single-dose crossover Test: CJ-30056 20/500mg Reference: Atorvastatin 20mg and Metformin XR 500mg Once daily Oral administration with 7days of washout period | Drug: Atorvastatin 20mg and Metformin XR 500mg (Reference)<br>* Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between. Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.<br>Drug: CJ-30056 20/500mg (Test)<br>* Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between. Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of Atorvastatin |  | Upto 36 hours | 
| Maximum plasma concentration (Cmax) of Metformin |  | Upto 24 hours | 
| Area Under the plasma concentration-time Curve (AUC0-t) of Atorvastatin |  | Upto 36 hours | 
| Area Under the plasma concentration-time Curve (AUC0-t) of Metformin |  | Upto 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of 2-OH-atorvastatin |  | Upto 36 hours | 
| Area Under the plasma concentration-time Curve (AUC0-t) of 2-OH-atorvastatin |  | Upto 36 hours | 
| CL/F of Atorvastatin and Metformin |  | Upto 36 hours | 
| Vd/F of Atorvastatin and Metformin |  | Upto 36 hours |