Clinical Trial to Investigate the Efficacy and Safety of DWJ1351

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers

Detailed Description
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The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers.

Official Title
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An Open-label, Randomized, 2X2 Crossover Study to Compare the Pharmacokinetics and Safety Between DWJ1351 and Co-administration of Amlodipine/Olmesartan and Rosuvastatin in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)
* Drug: Sevikar and Crestor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject who provided written informed consent to participate in this study Healthy adult male subjects aged 19 to 50 years Subjects whose body weight ≥ 55 kg and Body Mass Index(BMI) ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 Subject who was judged to be healthy and suitable for the participation by the investigator based on screening test results Exclusion Criteria: Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs Subjects who had a serious clinical illness that can impact fate of drugs absorption Subject who shows vital signs with the number of systolic blood pressure of >140 mmHg or <100 mmHg, and the number of diastolic blood pressure of >90mmHg or <65mmHg Subject who have experienced drug abuse Subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month) Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 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: Test Drug<br>DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) | Drug: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)<br>* DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) X 1 tablet followed by Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet (after washout period)<br>* Other names: DWJ1351;|
| Active Comparator: Reference Drug<br>Sevikar and Crestor | Drug: Sevikar and Crestor<br>* Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet followed by FDC Amlodipine/Olmesartan/Rosuvastatin X 1 tablet (after washout period)<br>* Other names: Amlodipine/Olmesartan and Rosuvastatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | AUC | [ Time Frame: 0 - 72 hours ] | 
| Cmax | Cmax | [ Time Frame: 0 - 72 hours ] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf | AUCinf | [ Time Frame: 0 - 72 hours ] | 
| Tmax | Tmax | [ Time Frame: 0 - 72 hours ] | 
| t1/2β | t1/2β | [ Time Frame: 0 - 72 hours ] | 
| CL/F | CL/F | [ Time Frame: 0 - 72 hours ] | 
| Vdss/F | Vdss/F | [ Time Frame: 0 - 72 hours ] |