NL-OMON51608已完成不适用
A phase 1, open-label, 1-sequence crossover drug-drug-interaction study to assess the effect of single and multiple doses of CKD-506 on the single-dose pharmacokinetics of midazolam, a CYP3A4 substrate, in healthy male subjects. - CKD-506 DDI study with midazolam.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
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
- 18 至 64（—）
入选标准
- •1. Sex : Male.
- •2. Age : 20 to 49 years, inclusive, at screening.
- •3. Body mass index : 18.0 to 30.0 kg/m2, inclusive, at screening.
- •4. Weight : >=50 kg at screening.
- •5. Status : Healthy subjects.
- •6. Race : Caucasian only (ie, a white person having origins in any of the
- •original peoples of Europe, the Middle East, or North Africa).
- •+ Further criteria apply, see protocol.
排除标准
- •1. Previous participation in the current study.
- •2. Employee of PRA or the Sponsor.
- •3. History of relevant drug and/or food allergies.
- •4. Using tobacco products within 60 days prior to the first drug administration.
- •5. History of alcohol abuse or drug addiction (including soft drugs like
- •cannabis products) within 2 years prior to admission to the clinical research
- •+ Further criteria apply, see protocol.
研究者
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