NCT02504606已完成1 期
A Randomized, Open-label, Single Dose, 2-Treatment, 2-Period, 2-Way Crossover Study to Assess Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Change from baseline in blood concentration of Amlodipine
研究概览
简要总结
This clinical trial was evaluated to compare the safety and pharmacokinetics of Besylsartan with Amosartan, which was available commercially after single oral dose in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 18 and 30
- •Healthy as determined by a responsible physician
排除标准
- •History of clinically significant disease
- •Any chronic disease
- •Creatine clearance less than 50ml/min
- •Hypotension (100mmHg/60mmHg)
- •Treatment of barbital type drug within 1 month
- •Administration of herbal medicine within 7 days
研究组 & 干预措施
Besylsartan
Experimental
amlodipine besylate 6.944mg+losartan K 100mg
干预措施: Besylsartan (Drug)
Amosartan
Active Comparator
amlodipine besylate 7.841mg+losartan K 100mg
干预措施: Amosartan (Drug)
结局指标
主要结局
Change from baseline in blood concentration of Amlodipine
时间窗: 144 hour
Detect the change of blood concentration of Amlodipine by LC-MS/MS
Change from baseline in blood concentration of Losartan
时间窗: 10 hour
Detect the change of blood concentration of Losartan by LC-MS/MS
次要结局
未报告次要终点
研究者
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