Study of DWJ1351 in Healthy Male Volunteers

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

Official Title
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A Randomized, Open-label, Single-Dose, 2-Way Cross-over Study To Compare the Safety and Pharmacokinetic Characteristics of Combination of Amlodipine, Olmesartan and Rosuvastatin and DWJ1351 in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: DWJ1351
* Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Subject who provided written informed consent to participate in this study Exclusion Criteria: Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs Subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, digestive system, reproductive system, neurology, psychology, ophthalmic and skin disease 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 ≥150 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥100mmHg or ≤66mmHg 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AB<br>Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) followed by DWJ1351 | Drug: DWJ1351<br> <br> Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)<br> <br> |
| Experimental: BA<br>DWJ1351 followed by Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) | Drug: DWJ1351<br> <br> Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC |  | 0 - 144 hr | 
| Cmax |  | 0 - 144 hr |