Phase Ⅰ Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet

Study Overview
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Brief Summary
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The objectives of this study are: To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers

Official Title
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A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Years 20-45 18 ≤ BMI < 27kg/m² volunteer Exclusion Criteria: Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing Subject with symptoms of acute disease within 28days prior to study medication dosing Subject with gastrointestinal diseases or surgery which might significantly change absorption of medicines Use of any prescription medication within 14 days prior to study medication dosing and over-the-counter medication including oriental medication within 7 days prior to study medication dosing Subject with known for hypersensitivity reaction to amlodipine and valsartan 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. eGFR< 50mL/min ⅳ. continued serum potassium concentration abnormal status (on baseline visit, < 3.5mEq/L or > 5.5mEq/L) Positive test results for HBs Ab, HCV Ab, Syphilis regain test Drug abuse or continued excessive use of caffeine (caffeine > five cups/day), severe heavy smoker (cigarette > 10 cigarettes per day) and alcohol(alcohol>30g/day) Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice Clinically significant hypotension(SBP < 100mmHg, DBP ≤65mmHg) or hypertension(SBP 100mmHg, DBP < 65mmHg) when screening period Participation in any clinical investigation within 60days prior to study medication dosing Subjects with whole blood donation within 60days, component blood donation within 20days and blood transfusion within 30days prior to study medication dosing 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

Ages Eligible for Study
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Minimum Age: 20 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CJ Amlodipine/Valsartan 10/160mg<br> | Drug: CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg<br>* single dose<br>|
| Active Comparator: Novartis Exforge 10/160mg<br> | Drug: CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg<br>* single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic parameters of amlodipine and valsartan(Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast)) |  | Up to 144 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf, Tmax, T1/2, CL/F |  | up to 144 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Pharmacokinetics