A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers

Study Overview
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Brief Summary
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a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

Detailed Description
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A sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

Official Title
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A Sequence-randomized, Open-label, 3-way Crossover, Single Oral Dose Clinical Trial to Investigate the Pharmacokinetic Characteristics and Safety/Tolerability According to Formulations of CKD-386 in Healthy Male Volunteers

Conditions
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Hypertension, Dyslipidemias

Intervention / Treatment
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* Drug: CKD-386 formulation 1
* Drug: CKD-386 formulation 2
* Drug: D326, D337 and D013


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers aged between ≥20 and ≤45 years old Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2 Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial Exclusion Criteria: History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests

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: Sequence 1<br>Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(3 tabs, once) | Drug: CKD-386 formulation 1<br>* A single oral dose of 1 tablet under fasting conditions for each period<br>* Other names: CKD-386 Test 1;Drug: CKD-386 formulation 2<br>* A single oral dose of 1 tablet under fasting conditions for each period<br>* Other names: CKD-386 Test 2;Drug: D326, D337 and D013<br>* A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period<br>* Other names: CKD-386 Reference;|
| Experimental: Sequence 2<br>Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(1 tab, once) | Drug: CKD-386 formulation 1<br>* A single oral dose of 1 tablet under fasting conditions for each period<br>* Other names: CKD-386 Test 1;Drug: CKD-386 formulation 2<br>* A single oral dose of 1 tablet under fasting conditions for each period<br>* Other names: CKD-386 Test 2;Drug: D326, D337 and D013<br>* A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period<br>* Other names: CKD-386 Reference;|
| Experimental: Sequence 3<br>Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(1 tab, once) | Drug: CKD-386 formulation 1<br>* A single oral dose of 1 tablet under fasting conditions for each period<br>* Other names: CKD-386 Test 1;Drug: CKD-386 formulation 2<br>* A single oral dose of 1 tablet under fasting conditions for each period<br>* Other names: CKD-386 Test 2;Drug: D326, D337 and D013<br>* A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period<br>* Other names: CKD-386 Reference;|
| Experimental: Sequence 4<br>Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013 | Drug: CKD-386 formulation 1<br>* A single oral dose of 1 tablet under fasting conditions for each period<br>* Other names: CKD-386 Test 1;Drug: CKD-386 formulation 2<br>* A single oral dose of 1 tablet under fasting conditions for each period<br>* Other names: CKD-386 Test 2;Drug: D326, D337 and D013<br>* A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period<br>* Other names: CKD-386 Reference;|
| Experimental: Sequence 5<br>Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(1 tab, once) | Drug: CKD-386 formulation 1<br>* A single oral dose of 1 tablet under fasting conditions for each period<br>* Other names: CKD-386 Test 1;Drug: CKD-386 formulation 2<br>* A single oral dose of 1 tablet under fasting conditions for each period<br>* Other names: CKD-386 Test 2;Drug: D326, D337 and D013<br>* A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period<br>* Other names: CKD-386 Reference;|
| Experimental: Sequence 6<br>Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(1 tab, once) | Drug: CKD-386 formulation 1<br>* A single oral dose of 1 tablet under fasting conditions for each period<br>* Other names: CKD-386 Test 1;Drug: CKD-386 formulation 2<br>* A single oral dose of 1 tablet under fasting conditions for each period<br>* Other names: CKD-386 Test 2;Drug: D326, D337 and D013<br>* A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period<br>* Other names: CKD-386 Reference;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013 | AUC0-t: Area under the concentration-time curve from time zero to time | 0(predose) 72 hour at Day1 Day3, Day15 Day17, Day29 Day31 | 
| Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013 | Cmax: Maximum plasma concentration of the drug | 0(predose) 72 hour at Day1 Day3, Day15 Day17, Day29 Day31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | AUCinf: Area under the concentration-time curve from zero up to ∞ | 0(predose) 72 hour at Day1 D3, Day15 D17, Day29 31 | 
| Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | Tmax: Time to maximum plasma concentration | 0(predose) 72 hour at Day1 Day3, Day15 Day17, Day29 Day31 | 
| t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | t1/2: Terminal elimination half-life | 0(predose) 72 hour at Day1 Day3, Day15 Day17, Day29 Day31 | 
| CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | CL/F: Apparent total body clearance of the drug | 0(predose) 72 hour at Day1 Day3, Day15 Day17, Day29 Day31 | 
| Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | Vd/F: Apparent volume of distribution | 0(predose) 72 hour at Day1 Day3, Day15 Day17, Day29 Day31 | 
| AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | AUC0-t: Area under the concentration-time curve from time zero to time | 0(predose) 72 hour at Day1 Day3, Day15 Day17, Day29 Day31 | 
| Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | Cmax: Maximum plasma concentration of the drug | 0(predose) 72 hour at Day1 Day3, Day15 Day17, Day29 Day31 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD-386, Pharmacokinetics, D326, D337, D013