KCT0000326已完成未知
A double-blind, randomized, placebo-controlled, phase I study to assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of repeated daily doses of 3, 10 and 30mg of macitentan in Korean healthy male subjects
Actelion Pharmaceuticals Korea0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 50(Year)（—）
- 性别
- Male
入选标准
- •1. Healthy Korean adult males
- •2. Aged 20 to 50 years, inclusive, at screening
- •3. Healthy on the basis of medical history and the assessments performed at screening
排除标准
- •1. History of clinically relevant hypersensitivity or serious adverse reactions to any drug
- •2. Abnormal values that suggest a clinically significant underlying disease or subject with the following lab abnormalities:
- •1)Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 1.25 × the upper limits of normal
- •2)Total bilirubin > 1.5 × the upper limits of normal
研究者
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