To Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers

Study Overview
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Brief Summary
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To evaluate the pharmacokinetics and the safety of ID14009 compared to coadministration of ID1805 with ID1803 in healthy adult volunteers.

Official Title
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An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over, Clinical Trial to Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers.

Conditions
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Dyslipidemias, Hypertension

Intervention / Treatment
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* Combination Product: ID140009
* Combination Product: ID1803+ID1805


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult volunteers aged over 19 years Subjects who have over 50kg and BMI more than 18.5kg/m^2 and less than 29.9kg/m^2 Subjects who are eligible for this study as determined by clinical laboratory test results, urine test results, vital sign measurements, 12-lead ECG results, and physical examination findings during screening. Subjects must agree to practice a medically acceptable method of birth control and should not donate sperm or eggs until 28 days after last dose of study drug. Subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period Exclusion Criteria: • Subject with any clinically significant cardiovascular, respiratory, endocrinology, infectious disease, ophthalmology, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease History of gastrointestinal disease (except for appendectomy or herniotomy) or surgery (ex. Crohn's disease, ulcer) that may affect the absorption of a given drug Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug Subject with symptoms of acute disease within 28days prior to study medication dosing Drugs or other drugs (aspirin, antibiotics, etc.) that contain the following drug categories or components of the same strain have an overactive or clinically significant history of hypersensitivity: Subject with a history of drug abuse or urinalysis positive Subject with clinically significant active chronic disease Subject with genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption. Genetic myopathic disorder or related family history Positive test results for HBs Ab, HCV Ab, Anti HIV(AIDS), RPR Ab Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug) Subject who cannot take standard meal in hospitalization Present history of hypothyroidism or clinically significant assay Subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration. Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing Smokers whose average daily smoking amount exceeds 10 cigarettes per day within 3 months before the first dosing day and those who can't quit from 48 hours before dosing to the time of the last blood sampling. Subjects who judged ineligible by the investigator

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

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: ID140009<br> | Combination Product: ID140009<br>* Combination Product: ID140009 Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg/ Amlodipine 10mg/ Valsartan 160mg<br>|
| Active Comparator: ID1803+ID1805<br> | Combination Product: ID1803+ID1805<br>* (Amlodipine 10mg/Valsartan 160mg)+(Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine) | Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: AUCt | 0 72hr | 
| Cmax (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine) | Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: Cmax | 0 72hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt (Free Ezetimibe) | Free Ezetimibe: AUCt | 0 72hr | 
| Cmax (Free Ezetimibe) | Free Ezetimib: Cmax | 0 72hr |