A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine 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 when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.

Detailed Description
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This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Amlodipine and co-administration of Fimasartan and Amlodipine.

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 a Fixed Dose Combination of Fimasartan/Amlodipine and Co-administration of Fimasartan and Amlodipine in Healthy Male Volunteers

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Fimasartan/Amlodipine
* Drug: Fimasartan + Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male 19-50 years of age. Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening. Medically healthy with no clinically significant medical history. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol. Exclusion Criteria: History or presence of clinically significant medical or psychiatric condition or disease. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). Seated blood pressure is less than 100/65 mmHg or greater than 140/90 mmHg at screening. Plasma donation within a month prior to the first dose of study drug. Participation in another clinical trial within 3 months prior to the first dose of study drug(s).

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: Other
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 A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 14 days between the each period. | Drug: Fimasartan/Amlodipine<br>* Treatment B<br>Drug: Fimasartan + Amlodipine<br>* Treatment A<br>|
| Experimental: Sequence B<br>Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 14 days between the each period. | Drug: Fimasartan/Amlodipine<br>* Treatment B<br>Drug: Fimasartan + Amlodipine<br>* Treatment A<br>|
| Experimental: Sequency C<br>Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 14 days between the each period. | Drug: Fimasartan/Amlodipine<br>* Treatment B<br>Drug: Fimasartan + Amlodipine<br>* Treatment A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax and AUClast of Fimasartan, Amlodipine |  | Time Frame: 0 144 hour after medication | 

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