Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337

Study Overview
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Brief Summary
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Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337 combination

Official Title
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Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337 in Healthy Adult Volunteers

Conditions
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Hyperlipidemias

Intervention / Treatment
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* Drug: T
* Drug: R


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 19 aged and 45 aged in healthy male adult Over 50 kg, BMI between 18.0-29.0 kg/m2 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 Subjects with abnormal lab values at least one below 1) AST or ALT>2 fold of upper normal limit 2) Total bilirubin>2 fold of upper normal limit 3) CK>2 fold of upper normal limit 4) Estimated Glomerular filtration rate<60mL/min/1.73m2 Drink over 21 units/week (1 unit= 10g=12.5mL of pure alcohol) or unable to stop drinking during clinical trials Smoke over 10 cigarettes per day or unable to stop smoking Subjects who previously participated in other clinical trials within 90 days Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 10 days. Taking medications which induce or block medication metabolism History of drug abuse Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days. 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: A (R+T+R+T)<br>Period 1 : R Period 2 : T Period 3 : R Period 4 : T | Drug: T<br>* CKD-391 40/10mg<br>* Other names: Test Drug;Drug: R<br>* D086 and D337 co-administration<br>* Other names: Reference drug;|
| Active Comparator: B (T+R+T+R)<br>Period 1 : T Period 2 : R Period 3 : T Period 4 : R | Drug: T<br>* CKD-391 40/10mg<br>* Other names: Test Drug;Drug: R<br>* D086 and D337 co-administration<br>* Other names: Reference drug;|

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 | 0 72hours | 
| AUCt | To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt | 0 72hours |