JPRN-jRCT2080224786已完成1 期
A Clinical Pharmacology Study of RTA 402 (Investigation of the Effect of Food on the Pharmacokinetics of RTA 402 Capsules in Japanese Healthy Adults and Comparison of the Pharmacokinetics with Those in Caucasian Healthy Adults)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 39age old（—）
- 性别
- Male
入选标准
- •1) Written voluntary informed consent to participate in the study;
- •[Food Effect Part] Japanese men 20 to <40 years of age at informed consent;
- •[Caucasian Subject Part] Caucasian men 20 to <40 years of age at informed consent;
- •3) BMI 18.5 kg/m2 to <25.0 kg/m2 at screening
排除标准
- •1) Presence of any disease requiring treatment;
- •2) History of heart failure (e.g., history of diagnosis of congestive heart failure categorized as Class III or IV of the New York Heart Association (NYHA) Functional Classification or history of hospitalization due to heart failure);
- •3) Alcoholism or drug addiction, or any positive result on drug abuse testing;
- •4) History of or current drug allergy;
- •5) Any positive result on infectious disease testing.;
研究者
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