Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405

Study Overview
=================
Brief Summary
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The purpose of this study is to investigate the pharmacokinetic interaction and safety between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy male volunteers

Official Title
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A Randomized, Open-label, 4-way Crossover Single Dose Clinical Trial to Investigate the Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405 When Administered Alone and in Combination in Healthy Male Volunteers

Conditions
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Hypertension(HTN)

Intervention / Treatment
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* Drug: HGP0904
* Drug: HGP0608
* Drug: HGP1405


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 45 years old Healthy men Exclusion Criteria: Gastroentestinal disease affecting drug absorption

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?
-----------------

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: HGP0904+HGP0608+HGP1405<br>amlodipine + losartan + chlorthalidone | Drug: HGP0904<br> <br> * Other names: amlodipine;Drug: HGP0608<br> <br> * Other names: losartan;Drug: HGP1405<br> <br> * Other names: chlorthalidone;|
| Active Comparator: HGP0904<br>amlodipine | Drug: HGP0904<br> <br> * Other names: amlodipine;|
| Active Comparator: HGP0608<br>losartan | Drug: HGP0608<br> <br> * Other names: losartan;|
| Active Comparator: HGP1405<br>chlorthalidone | Drug: HGP1405<br> <br> * Other names: chlorthalidone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast | AUClast(Area under the curve to the last measurable concentration) | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr | 
| Cmax | Cmax(maxium concentration) | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf | AUCinf(Area under the curve to infinity) | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr | 
| Tmax | Tmax(Time to maximum concentration) | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr | 
| T1/2 | T1/2(Terminal elimination half-life), | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr | 
| CL/F | CL/F(Apparent clearance) | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr | 
| Vz/F | Vz/F(Apparent volume of distribution) | 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr |