Compare the Pharmacokinetics and Safety of CKD-333 With Co-administration CKD-330 and D090 in Healthy Male Adults

Study Overview
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Brief Summary
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The object of clinical trial is to investigate the pharmacokinetics and safety compared to CKD-333 and co-administration CKD-330, D090 under fasting condition in healthy male adults.

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 D090 in healthy male adults

Official Title
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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 D090 in Healthy Male Adults

Conditions
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Hypertension, Dyslipidemias

Intervention / Treatment
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* Drug: CKD-333, formula I
* Drug: CKD-333, formula II
* Drug: CKD-330, D090


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male adults aged 19 to 45 years Body weight more than 50kg and within ideal body weight ±20% signed informed consent form 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 Systolic Blood pressure≥140mmHg or Systolic Blood pressure<90mmHg, Diastolic Blood Pressure≥90mmHg or Diastolic Blood Pressure<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: CKD-333, formula I Period 2: CKD-333, formula II Period 3: CKD-330, D090 | Drug: CKD-333, formula I<br>* Test drug<br>Drug: CKD-333, formula II<br>* Test drug<br>Drug: CKD-330, D090<br>* Reference Drug<br>|
| Experimental: Group 2<br>Period 1: CKD-333, formula I Period 2: CKD-330, D090 Period 3: CKD-333, formula II | Drug: CKD-333, formula I<br>* Test drug<br>Drug: CKD-333, formula II<br>* Test drug<br>Drug: CKD-330, D090<br>* Reference Drug<br>|
| Experimental: Group 3<br>Period 1: CKD-333, formula II Period 2: CKD-330, D090 Period 3: CKD-333, formula I | Drug: CKD-333, formula I<br>* Test drug<br>Drug: CKD-333, formula II<br>* Test drug<br>Drug: CKD-330, D090<br>* Reference Drug<br>|
| Experimental: Group 4<br>Period 1: CKD-333, formula II Period 2: CKD-333, formula I Period 3: CKD-330, D090 | Drug: CKD-333, formula I<br>* Test drug<br>Drug: CKD-333, formula II<br>* Test drug<br>Drug: CKD-330, D090<br>* Reference Drug<br>|
| Experimental: Group 5<br>Period 1: CKD-330, D090 Period 2: CKD-333, formula I Period 3: CKD-333, formula II | Drug: CKD-333, formula I<br>* Test drug<br>Drug: CKD-333, formula II<br>* Test drug<br>Drug: CKD-330, D090<br>* Reference Drug<br>|
| Experimental: Group 6<br>Period 1: CKD-330, D090 Period 2: CKD-333, formula II Period 3: CKD-333, formula I | Drug: CKD-333, formula I<br>* Test drug<br>Drug: CKD-333, formula II<br>* Test drug<br>Drug: CKD-330, D090<br>* Reference Drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast of Candesartan | Area under the plasma concentration-time curve to last concentration of Candesartan | 0 hour   72 hour after drug administration | 
| AUClast of Amlodipine | Area under the plasma concentration-time curve to last concentration of Amlodipine | 0 hour   72 hour after drug administration | 
| AUClast of Atorvastatin | Area under the plasma concentration-time curve to last concentration of Atorvastatin | 0 hour   72 hour after drug administration | 
| Cmax of Candesartan | Maximum plasma concentration of Candesartan | 0 hour   72 hour after drug administration | 
| Cmax of Amlodipine | Maximum plasma concentration of Amlodipine | 0 hour   72 hour after drug administration | 
| Cmax of Atorvastatin | Maximum plasma concentration of Atorvastatin | 0 hour   72 hour after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of Candesartan | Area under the plasma concentration-time curve from zero to infinity concentration of Candesartan | 0 hour   72 hour after drug administration | 
| AUCinf of Amlodipine | Area under the plasma concentration-time curve from zero to infinity concentration of Amlodipine | 0 hour   72 hour after drug administration | 
| AUCinf of Atorvastatin | Area under the plasma concentration-time curve from zero to infinity concentration of Atorvastatin | 0 hour   72 hour after drug administration | 
| AUCinf of 2-hydroxy atorvastatin | Area under the plasma concentration-time curve from zero to infinity concentration of 2-hydroxy atorvastatin | 0 hour   72 hour after drug administration | 
| Tmax of Candesartan | Time to maximum plasma concentration of Candesartan | 0 hour   72 hour after drug administration | 
| Tmax of Amlodipine | Time to maximum plasma concentration of Amlodipine | 0 hour   72 hour after drug administration | 
| Tmax of Atorvastatin | Time to maximum plasma concentration of Atorvastatin | 0 hour   72 hour after drug administration | 
| Tmax of 2-hydroxy atorvastatin | Time to maximum plasma concentration of 2-hydroxy atorvastatin | 0 hour   72 hour after drug administration | 
| T1/2 of Candesartan | Half-life of Candesartan | 0 hour   72 hour after drug administration | 
| T1/2 of Amlodipine | Half-life of Amlodipine | 0 hour   72 hour after drug administration | 
| T1/2 of Atorvastatin | Half-life of Atorvastatin | 0 hour   72 hour after drug administration | 
| T1/2 of 2-hydroxy atorvastatin | Half-life of 2-hydroxy atorvastatin | 0 hour   72 hour after drug administration | 
| clearance of Candesartan | Apparent clearance of Candesartan | 0 hour   72 hour after drug administration | 
| clearance of Amlodipine | Apparent clearance of Amlodipine | 0 hour   72 hour after drug administration | 
| clearance of Atorvastatin | Apparent clearance of Atorvastatin | 0 hour   72 hour after drug administration | 
| clearance of 2-hydroxy atorvastatin | Apparent clearance of 2-hydroxy atorvastatin | 0 hour   72 hour after drug administration | 
| Vd/F of Candesartan | Apparent volume of distribution of Candesartan | 0 hour   72 hour after drug administration | 
| Vd/F of Amlodipine | Apparent volume of distribution of Amlodipine | 0 hour   72 hour after drug administration | 
| Vd/F of Atorvastatin | Apparent volume of distribution of Atorvastatin | 0 hour   72 hour after drug administration | 
| Vd/F of 2-hydroxy atorvastatin | Apparent volume of distribution of 2-hydroxy atorvastatin | 0 hour   72 hour after drug administration |