Study to Assess PK/PD Character, Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subject.

Study Overview
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Brief Summary
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Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects.

Detailed Description
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Open-label, Randomized, 3-period, 6-sequence, crossover study

Official Title
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Clinical Trial to Assess the Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subjects

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: CKD-519 50mg 2Tabs.
* Drug: CKD-519 100mg 1Tab.
* Drug: CKD-519 100mg 1Cap.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 20 aged and 45 aged in healthy male adult Body weight ≥ 50kg and in the range of calculated BMI(Body Mass Index) 18 29kg/m2 Subject who sign on an informed consent form willingly Necessarily he agrees that use double contraceptions and do not sperm donation until two months during clinical trials and after the final dosage of investigational products Exclusion Criteria: Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system Have a acute disease within 28 days before the beginning of study treatment Have a disease history that can effect drug absorption, distribution, metabolism, excretion Have a clinically significant chronic disease Systolic blood pressure <100mmHg or >140mmHg, diastolic blood pressure<60mmHg or >90mmHg Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories)) Subject treated ethical drug within 14 days before the beginning of study treatment Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs) Cannot take standard Meal Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing Blood transfusion within 30 days Taking drugs have received any other investigational drug within 90 days prior to the first dosing Continuously taking caffeine(>5 cups/day), drinking alcohol(>30g/day), smoking excessive cigarettes(>10cigarettes/day) Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasone(for example, noncompliance, a disobliging manner) Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days

Ages Eligible for Study
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Minimum Age: 20 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 1<br>A-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.) | Drug: CKD-519 50mg 2Tabs.<br>* after taking Standard meal, CKD-519 50mg 2Tabs. administration.<br>* Other names: Drug A;Drug: CKD-519 100mg 1Tab.<br>* after taking Standard meal, CKD-519 100mg 1Tab. administration.<br>* Other names: Drug B;Drug: CKD-519 100mg 1Cap.<br>* after taking Standard meal, CKD-519 100mg 1Cap. administration.<br>* Other names: Drug C;|
| Experimental: Group 2<br>B-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.) | Drug: CKD-519 50mg 2Tabs.<br>* after taking Standard meal, CKD-519 50mg 2Tabs. administration.<br>* Other names: Drug A;Drug: CKD-519 100mg 1Tab.<br>* after taking Standard meal, CKD-519 100mg 1Tab. administration.<br>* Other names: Drug B;Drug: CKD-519 100mg 1Cap.<br>* after taking Standard meal, CKD-519 100mg 1Cap. administration.<br>* Other names: Drug C;|
| Experimental: Group 3<br>C-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.) | Drug: CKD-519 50mg 2Tabs.<br>* after taking Standard meal, CKD-519 50mg 2Tabs. administration.<br>* Other names: Drug A;Drug: CKD-519 100mg 1Tab.<br>* after taking Standard meal, CKD-519 100mg 1Tab. administration.<br>* Other names: Drug B;Drug: CKD-519 100mg 1Cap.<br>* after taking Standard meal, CKD-519 100mg 1Cap. administration.<br>* Other names: Drug C;|
| Experimental: Group 4<br>A-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.) | Drug: CKD-519 50mg 2Tabs.<br>* after taking Standard meal, CKD-519 50mg 2Tabs. administration.<br>* Other names: Drug A;Drug: CKD-519 100mg 1Tab.<br>* after taking Standard meal, CKD-519 100mg 1Tab. administration.<br>* Other names: Drug B;Drug: CKD-519 100mg 1Cap.<br>* after taking Standard meal, CKD-519 100mg 1Cap. administration.<br>* Other names: Drug C;|
| Experimental: Group 5<br>B-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.) | Drug: CKD-519 50mg 2Tabs.<br>* after taking Standard meal, CKD-519 50mg 2Tabs. administration.<br>* Other names: Drug A;Drug: CKD-519 100mg 1Tab.<br>* after taking Standard meal, CKD-519 100mg 1Tab. administration.<br>* Other names: Drug B;Drug: CKD-519 100mg 1Cap.<br>* after taking Standard meal, CKD-519 100mg 1Cap. administration.<br>* Other names: Drug C;|
| Experimental: Group 6<br>C-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.) | Drug: CKD-519 50mg 2Tabs.<br>* after taking Standard meal, CKD-519 50mg 2Tabs. administration.<br>* Other names: Drug A;Drug: CKD-519 100mg 1Tab.<br>* after taking Standard meal, CKD-519 100mg 1Tab. administration.<br>* Other names: Drug B;Drug: CKD-519 100mg 1Cap.<br>* after taking Standard meal, CKD-519 100mg 1Cap. administration.<br>* Other names: Drug C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of CKD-519 |  | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h | 
| Tmax of CKD-519 |  | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h | 
| AUClast of CKD-519 |  | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h | 
| AUC0-∞ of CKD-519 |  | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h | 
| t1/2 of CKD-519 |  | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h | 
| CL/F of CKD-519 |  | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h | 
| Vd/F of CKD-519 |  | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h | 
| Emax of CKD-519 CETP(Cholesteryl ester transfer protein) Activity |  | 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h | 
| Tmax of CKD-519 CETP Activity |  | 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h | 
| AUEC of CKD-519 CETP Activity |  | 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h | 
| EC50(half maximal effective concentration ) of CKD-519 CETP Activity |  | 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h |