Essential Hypertension Clinical Trial
Official title:
An Open Label, Single-dosing, and Parallel Study in Healthy Elderly and Young Male Volunteers.
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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