Pharmacokinetics and Safety Profile of CKD-333

Study Overview
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Brief Summary
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Compare the pharmacokinetic characteristics and safety between CKD-333 tablet and CKD-330, D086 combination

Detailed Description
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An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-333 and coadministration of CKD-330 and D086 in healthy male adults

Official Title
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An Open-label, Randomized, Fasted, Single-dose, Three-way Crossover Study to Compare the Pharmacokinetics and Safety Between Administration of CKD-333 and Coadministration of CKD-330 and D086 in Healthy Male Adults

Conditions
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Hypertension, Dyslipidemias

Intervention / Treatment
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* Drug: CKD-333 formulation I
* Drug: CKD-333 formulation II
* Drug: CKD-330+D086


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 19 aged and 45 aged in healthy male adult Body weight more than 50kg and within ideal body weight ±20% Exclusion Criteria: Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness Have a gastrointestinal disease history that can effect drug absorption or surgery SBP(Systolic Blood pressure)≥140mmHg or SBP<90mmHg, DBP(Diastolic Blood Pressure(≥90mmHg or DBP<60mmHg

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 1<br>Period 1: Test drug 1(CKD-333 formulation I) Period 2: Test drug 2(CKD-333 formulation II) Period 3: Reference drug(CKD-330 + D086) | Drug: CKD-333 formulation I<br>* 1 tablet administered before the breakfast(single-dose)<br>* Other names: Test drug;Drug: CKD-333 formulation II<br>* 1 tablet administered before the breakfast(single-dose)<br>* Other names: Test drug;Drug: CKD-330+D086<br>* 2 tablet administered before the breakfast(single-dose)<br>* Other names: Reference drug;|
| Experimental: Group 2<br>Period 1: Test drug 1(CKD-333 formulation I) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 2(CKD-333 formulation II) | Drug: CKD-333 formulation I<br>* 1 tablet administered before the breakfast(single-dose)<br>* Other names: Test drug;Drug: CKD-333 formulation II<br>* 1 tablet administered before the breakfast(single-dose)<br>* Other names: Test drug;Drug: CKD-330+D086<br>* 2 tablet administered before the breakfast(single-dose)<br>* Other names: Reference drug;|
| Experimental: Group 3<br>Period 1: Test drug 2(CKD-333 formulation II) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 1(CKD-333 formulation I) | Drug: CKD-333 formulation I<br>* 1 tablet administered before the breakfast(single-dose)<br>* Other names: Test drug;Drug: CKD-333 formulation II<br>* 1 tablet administered before the breakfast(single-dose)<br>* Other names: Test drug;Drug: CKD-330+D086<br>* 2 tablet administered before the breakfast(single-dose)<br>* Other names: Reference drug;|
| Experimental: Group 4<br>Period 1: Test drug 2(CKD-333 formulation II) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Reference drug(CKD-330 + D086) | Drug: CKD-333 formulation I<br>* 1 tablet administered before the breakfast(single-dose)<br>* Other names: Test drug;Drug: CKD-333 formulation II<br>* 1 tablet administered before the breakfast(single-dose)<br>* Other names: Test drug;Drug: CKD-330+D086<br>* 2 tablet administered before the breakfast(single-dose)<br>* Other names: Reference drug;|
| Experimental: Group 5<br>Period 1: Reference drug(CKD-330 + D086) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Test drug 2(CKD-333 formulation II) | Drug: CKD-333 formulation I<br>* 1 tablet administered before the breakfast(single-dose)<br>* Other names: Test drug;Drug: CKD-333 formulation II<br>* 1 tablet administered before the breakfast(single-dose)<br>* Other names: Test drug;Drug: CKD-330+D086<br>* 2 tablet administered before the breakfast(single-dose)<br>* Other names: Reference drug;|
| Experimental: Group 6<br>Period 1: Reference drug(CKD-330 + D086) Period 2: Test durg 2(CKD-333 formulation II) Period 3: Test drug 1(CKD-333 formulation I) | Drug: CKD-333 formulation I<br>* 1 tablet administered before the breakfast(single-dose)<br>* Other names: Test drug;Drug: CKD-333 formulation II<br>* 1 tablet administered before the breakfast(single-dose)<br>* Other names: Test drug;Drug: CKD-330+D086<br>* 2 tablet administered before the breakfast(single-dose)<br>* Other names: Reference drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt(Area under the plasma drug concentration-time curve) PK of Candesartan, Amlodipine, Atorvastatin |  | 0 72hours | 
| Cmax(Maximum plasma concentration of the drug in plasma) of Candesartan, Amlodipine, Atorvastatin |  | 0 72hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf(Area under the plasma concentration-time curve from time t to infinity) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin |  | 0 72hours | 
| Tmax(Time to reach the maximum concentration) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin |  | 0 72hours | 
| t1/2(Time for Cmax to drop in half) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin |  | 0 72hours | 
| CL/F(Apparent clearance) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin |  | 0 72hours | 
| Vd/F(Apparent volume of distribution) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin |  | 0 72hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Dyslipidemias, CKD-333