Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60)

Study Overview
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Brief Summary
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To assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab

Detailed Description
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The purpose of this study is to assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.

Official Title
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Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects

Conditions
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Healthy Male Subjects

Intervention / Treatment
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* Drug: Exforge tab. 10/160mg
* Drug: Lodivixx tab. 5/160mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Years 20-45 Body weight ≥ 50kg and 18 ≤ BMI ≤ 29kg/m2 volunteer 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 Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug Subject with clinically significant active chronic disease Subject with any of the following conditions in laboratory test i. AST(sGOT) or ALT(sGPT) > Upper normal limit × 1.5 ii. Total bilirubin > Upper normal limit × 1.5 iii. renal failure with Creatinine clearance < 50mL/min Clinically significant hypotension when screening period (SBP < 100mmHg, DBP < 60mmHg) Positive test results for HBs Ab, HCV Ab, Syphilis regain test Use of any prescription medication within 14 days prior to study medication dosing Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug) Subject with known for hypersensitivity reaction to S-amlodipine, amlodipine and valsartan and dihydropyridine derivatives Subject who is not able to taking the institutional standard meal Subjects with whole blood donation within 60days, component blood donation within 20days Subjects receiving blood transfusion within 30days prior to study medication dosing Participation in any clinical investigation within 60days prior to study medication dosing Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker (cigarette > 10 cigarettes per day) Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing Continued serum potassium concentration abnormal status (on baseline visit, < 3.5mEq/L or > 5.5mEq/L) Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator Severe renal insufficient subjects (creatinine clearance : less than 10mL/min) Severe hepatic insufficient subjects,billiary cirrhosis, biliary obstruction and cholestasis patient Combination with aliskiren in Diabetic patient or moderate to severe renal insufficient subjects (glomerular filtration rate<60mL/min/1.73m2)

Ages Eligible for Study
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Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exforge tab. 10/160mg<br>amlodipine besylate (10mg as amlodipine) valsartan 160mg | Drug: Exforge tab. 10/160mg<br> <br> * Other names: - valsartan;|
| Experimental: Lodivixx tab. 5/160mg<br>S-amlodipine nicotinate (5mg as S-amlodipine) valsartan 160mg | Drug: Lodivixx tab. 5/160mg<br> <br> * Other names: - valsartan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum concentration) |  | Valsartan : 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48hr (15 points), S-amlodipine : 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 120, 168hr (18 points) | 
| AUC(area under curve) |  | Valsartan : 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48hr (15 points), S-amlodipine : 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 120, 168hr (18 points) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Participants will be followed for the duration of hospital stay, an expected average of 3 days and follow-up period for maximum 6 days from the discharge |