Study to Compare and Assess the Safety and Pharmacokinetic Characteristics After Oral Administration of Fimasartan (BR-A-657∙K) in Healthy Elderly and Young Male Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to compare and assess the safety and pharmacokinetic characteristics after oral administration of fimasartan (BR-A-657∙K) in healthy elderly and young male volunteers.

Detailed Description
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Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan (BR-A-657-K) 20 mg   480 mg single dosing with healthy subjects, demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose. A open-labeled, single-dosing, parallel Clinical Study to Evaluate pharmacokinetic characteristics after oral administration of fimasartan in healthy elderly and young male volunteers. 22 male healthy volunteers were enrolled during 2 months. In part A, 240 mg of fimasartan per day was taken once by younger male healthy volunteers in day 1. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration. In part B, 240 mg of hydrochlorothiazide per day was taken once by elderly male healthy volunteers in day 1. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration.

Official Title
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An Open Label, Single-dosing, and Parallel Study in Healthy Elderly and Young Male Volunteers.

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Fimasartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age young: 19-45 years elderly: more than 65 years sex: male body weight: greater than 55 kg Exclusion Criteria: patients with contraindication to angiotensin II receptor antagonist. patients with a history of liver, renal, gastrointestinal, hematological or cardiac diseases patients with history or diseases which might affect absorption of the drug patients with HIV, type B or C hepatitis smokers of 20 or more cigarettes per day

Ages Eligible for Study
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Minimum Age: 19 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Part A<br>Young male healthy volunteer | Drug: Fimasartan<br>* Fimasartan 240mg/day<br>|
| Active Comparator: Part B<br>Elderly male healthy volunteer | Drug: Fimasartan<br>* Fimasartan 240mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, AUClast, tmax, t1/2 |  | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fimasartan, healthy elderly and young male volunteer, pharmacokinetic