Drug Interaction Study of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the Drug interaction and safety of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers.

Official Title
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An Open-label, Randomized, Single Dose, 6-Sequence, 3-Period, Cross-over Study to Evaluate a Drug Interaction Between Fixed-dose Combination of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male Subjects

Conditions
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Drug-Drug Interaction

Intervention / Treatment
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* Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy Male adults aged 19-50 years Exclusion Criteria: History or presence of clinically significant medical or psychiatric condition or disease. Hypersensitivity to ingredient of IP and other medication, food. Participation in any other study within 3months. History of whole blood donation within 2months and Apheresis 1month.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 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 |
| --- | --- |
| Other: Arm1(N=6)<br>Fimasartan/Amlodipine combination drug, Hydrochlorothiazide | Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide<br>* Fimasartan/Amlodipine combination drug, Hydrochlorothiazide<br>* Other names: FAH;|
| Other: Arm2(N=6)<br>Fimasartan/Amlodipine combination drug, Hydrochlorothiazide | Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide<br>* Fimasartan/Amlodipine combination drug, Hydrochlorothiazide<br>* Other names: FAH;|
| Other: Arm3(N=6)<br>Fimasartan/Amlodipine combination drug, Hydrochlorothiazide | Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide<br>* Fimasartan/Amlodipine combination drug, Hydrochlorothiazide<br>* Other names: FAH;|
| Other: Arm4(N=6)<br>Fimasartan/Amlodipine combination drug, Hydrochlorothiazide | Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide<br>* Fimasartan/Amlodipine combination drug, Hydrochlorothiazide<br>* Other names: FAH;|
| Other: Arm5(N=6)<br>Fimasartan/Amlodipine combination drug, Hydrochlorothiazide | Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide<br>* Fimasartan/Amlodipine combination drug, Hydrochlorothiazide<br>* Other names: FAH;|
| Other: Arm6(N=6)<br>Fimasartan/Amlodipine combination drug, Hydrochlorothiazide | Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide<br>* Fimasartan/Amlodipine combination drug, Hydrochlorothiazide<br>* Other names: FAH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma | 0 48hours after medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | AUCt(Area under the curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine, Hydrochlorothiazide | 0 48hours after medication |