Combination 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 Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers.

Official Title
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A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between BR1010 and Co-administration of BR1010-1 and BR1010-2 in Healthy Volunteers

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: Treatment T
* Drug: Treatment R


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy 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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All

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: Sequence A<br>Period 1(Treatment R) - Period 2(Treatment R) - Period 3(Treatment T) There will be a 14 washout of days between the each period. | Drug: Treatment T<br>* Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide<br>* Other names: FAH;Drug: Treatment R<br>* Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide<br>* Other names: FA/H;|
| Experimental: Sequence B<br>Period 1(Treatment R) - Period 2(Treatment T) - Period 3(Treatment R) There will be a 14 washout of days between the each period. | Drug: Treatment T<br>* Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide<br>* Other names: FAH;Drug: Treatment R<br>* Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide<br>* Other names: FA/H;|
| Experimental: Sequence C<br>Period 1(Treatment T) - Period 2(Treatment R) - Period 3(Treatment R) There will be a 14 washout of days between the each period. | Drug: Treatment T<br>* Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide<br>* Other names: FAH;Drug: Treatment R<br>* Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide<br>* Other names: FA/H;|

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 144hours after Medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf | Area under the plasma concentration versus time curve  of Fimasartan, Amlodipine, Hydrochlorothiazide | 0 144hours after medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension