To Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Adults

Study Overview
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Brief Summary
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This study is designated to evaluate the pharmacokinetic interactions of valsartan, amlodipine besylate, rosuvastatin, and ezetimibe in healthy male volunteers.

Detailed Description
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An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period phase 1 study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety between ID1801 and ID1803 in Healthy Male Subjects

Official Title
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An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period Phase 1 Study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Subjects

Conditions
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Hypertension, Dyslipidemias

Intervention / Treatment
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* Combination Product: ID1803
* Combination Product: ID1801
* Combination Product: ID1803+ID1801


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male volunteers aged 19 to 45 years Subjects who have over 50kg and BMI more than 18.5kg/m2 and less than 29.9kg/m2 Males must be agree to practice a medically acceptable method* of birth control and will not donate sperm during the study. 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 serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease Subject with symptoms of acute disease within 28days prior to study medication dosing Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug 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
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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ID1801<br>qd daily for 6days Intervention: Drug: administration of ID1801 for 6days. | Combination Product: ID1801<br>* Ezetimibe 10mg/Rosuvastatin Ca 20.8mg<br>|
| Active Comparator: ID1803<br>qd daily for 10days Intervention: Drug: administration of ID1803 for 10days. | Combination Product: ID1803<br>* Amlodipine 10mg/Valsartan 160mg<br>|
| Experimental: ID1801 and ID1803<br>qd daily for 7days Intervention: Drug: administration of ID1801 and ID1803. | Combination Product: ID1803+ID1801<br>* Amlodipine 10mg/Valsartan 160mg Ezetimibe 10mg/Rosuvastatin Ca 20.8mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ(Amlodipine, valsartan, rosuvastatin, free ezetimibe) | Amlodipine, valsartan, rosuvastatin, free ezetimibe: AUCτ | 0 72hours | 
| Cmax,ss(Amlodipine, valsartan, rosuvastatin, free ezetimibe) | Amlodipine, valsartan, rosuvastatin, free ezetimibe: Cmax,ss | 0 72hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss | N-desmethyl rosuvastatin, total ezetimibe: AUCτ | 0 72hours | 
| Cmax,ss(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss | N-desmethyl rosuvastatin, total ezetimibe: Cmax,ss | 0 72hours | 
| Cmin,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Cmin,ss | 0 72hours | 
| Tmax,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Tmax,ss | 0 72hours | 
| t1/2(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: t1/2 | 0 72hours | 
| CLss/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: CLss/F | 0 72hours | 
| Vd/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Vd/F | 0 72hours | 
| PTF(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: PTF | 0 72hours |