Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor 20mg/Glucophage SR 750mg

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 20mg and metformin SR 750mg, in healthy volunteers.

Detailed Description
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To evaluate the bioequivalence of of CJ-30056 and co-administration of atorvastatin 20mg and metformin SR 750mg

Official Title
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A Randomized, Open-labeled, Single-dose, Crossover Design Clinical Trial to Evaluate Pharmacokinetics and Safety of CJ-30056 20/750mg and Co-administration of Lipitor® 20mg and Glucophage SR 750mg in Fed Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Atorvastatin 20mg and Metformin SR 750mg
* Drug: CJ-30056 20/750mg


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 28 days before dosing Symptom of an acute illness within 28 days 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 Subjects who have genetic problems (galactose intolerance, Lapp lactase deficiency, glucose-galactase malabsorption etc.) 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 > 400mg/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: CJ-30056 20/750mg<br>fixed-dose combination of Atorvastatin 20mg and Metformin SR 750mg | Drug: Atorvastatin 20mg and Metformin SR 750mg<br>* co-administration of Atorvastatin 20mg and Metformin SR 750mg<br>* Other names: Atorvastatin (Lipitor) and Metformin (Glucophage SR);Drug: CJ-30056 20/750mg<br>* fixed-dosed combination of Atorvastatin 20mg and Metformin SR 750mg<br>* Other names: not yet approved;|
| Experimental: Atorvastatin 20mg and Metformin SR 750mg<br>co-administration of Atorvastatin 20mg and Metformin SR 750mg | Drug: Atorvastatin 20mg and Metformin SR 750mg<br>* co-administration of Atorvastatin 20mg and Metformin SR 750mg<br>* Other names: Atorvastatin (Lipitor) and Metformin (Glucophage SR);Drug: CJ-30056 20/750mg<br>* fixed-dosed combination of Atorvastatin 20mg and Metformin SR 750mg<br>* Other names: not yet approved;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of Atorvastatin and Metformin |  | Up to 32 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve(AUC) of Atorvastatin and Metformin |  | Up to 32 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volunteers