An Open Label, Single-dosing, and Parallel Study in Healthy Elderly and Young Male Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Cmax, AUClast, tmax, t1/2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •young: 19-45 years
- •elderly: more than 65 years
- •sex: male
- •body weight: greater than 55 kg
排除标准
- •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
研究组 & 干预措施
Part A
Young male healthy volunteer
干预措施: Fimasartan (Drug)
Part B
Elderly male healthy volunteer
干预措施: Fimasartan (Drug)
结局指标
主要结局
Cmax, AUClast, tmax, t1/2
时间窗: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h
次要结局
未报告次要终点