NCT01823913已完成1 期
Safety and Pharmacokinetic Comparison of Exforge® and G-0081 in Healthy Male Volunteers
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
- 50
- 试验地点
- 1
- 主要终点
- Profile of Pharmacokinetics
研究概览
简要总结
This study investigates safety and pharmacokinetic comparison of G-0081, a combination tablet of amlodipine and valsartan (test formulation), and Exforge®, a combination tablet of amlodipine and valsartan (reference formulation) for single dose in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease
排除标准
- •History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
- •Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
- •Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
- •Use of any substance that could induce or inhibit drug metabolism enzymes
研究组 & 干预措施
Test and reference formulations
Experimental
Test formulation and reference formulation given orally 14 days apart in a fasted state
干预措施: Test formulation (Drug)
Test and reference formulations
Experimental
Test formulation and reference formulation given orally 14 days apart in a fasted state
干预措施: Reference formulation (Drug)
结局指标
主要结局
Profile of Pharmacokinetics
时间窗: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose
Cmax, Area Under Curve(0 to the last sampling time)
次要结局
- Profile of Pharmacokinetics(0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose)
研究者
Kyungsoo Park
Associate Professor
Severance Hospital
研究点 (1)
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