Compare the Pharmacokinetics and Safety of CKD-391

Study Overview
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Brief Summary
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phase I clinical trial to compare the pharmacokinetics and safety of CKD-391 with co-administration of D090 and D337 in healthy adult volunteers

Official Title
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Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D090 and D337 in Healthy Adult Volunteers

Conditions
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Hyperlipidemias

Intervention / Treatment
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* Drug: CKD-391 10/10mg
* Drug: D090, D337


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 19 aged and 45 aged in healthy male adult Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations. Not abnormal or not clinically significant lab values. Subjects who signed informed consent form with good understandings after explanations by investigators. Exclusion Criteria: No history or presence of clinically significant diseases. Subjects showing adverse reaction to investigational product Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption. History of myopathy unable to stop drinking and smoking during clinical trials Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days History of drug abuse Disagree to contraception Subjects who are in any conditions impossible participating in the clinical trials

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: Group A<br>R+R+T+T Period 1 : R Period 2 : R Period 3 : T Period 4 : T | Drug: CKD-391 10/10mg<br>* Drug T: CKD-391 10/10mg(Other Name: Test Drug)<br>* Other names: Test Drug (T);Drug: D090, D337<br>* D090 and D337 co-administration(Other Name: Reference drug)<br>* Other names: Reference Drug (R);|
| Experimental: Group B<br>R+T+R+T Period 1 : R Period 2 : T Period 3 : R Period 4 : T | Drug: CKD-391 10/10mg<br>* Drug T: CKD-391 10/10mg(Other Name: Test Drug)<br>* Other names: Test Drug (T);Drug: D090, D337<br>* D090 and D337 co-administration(Other Name: Reference drug)<br>* Other names: Reference Drug (R);|
| Experimental: Group C<br>T+R+T+R Period 1 : T Period 2 : R Period 3 : T Period 4 : R | Drug: CKD-391 10/10mg<br>* Drug T: CKD-391 10/10mg(Other Name: Test Drug)<br>* Other names: Test Drug (T);Drug: D090, D337<br>* D090 and D337 co-administration(Other Name: Reference drug)<br>* Other names: Reference Drug (R);|
| Experimental: Group D<br>T+T+R+R Period 1 : T Period 2 : T Period 3 : R Period 4 : R | Drug: CKD-391 10/10mg<br>* Drug T: CKD-391 10/10mg(Other Name: Test Drug)<br>* Other names: Test Drug (T);Drug: D090, D337<br>* D090 and D337 co-administration(Other Name: Reference drug)<br>* Other names: Reference Drug (R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax 1) Atorvastatin, unconjugated ezetimibe(Cmax) | 0 72hours | 
| AUCt | To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt 1) Atorvastatin, unconjugated ezetimibe(AUCt) | 0 72hours |