JPRN-jRCT2080223097未知1 期
A single-center, open-label, single-dose study investigating the safety, tolerability, and pharmacokinetic properties of nalmefene 10 mg tablets in healthy Japanese male subjects
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 7
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 <= 45age old（—）
- 性别
- Male
入选标准
- •The subject is able to read and understand the informed consent form (ICF).
- •- The subject has a body mass index (BMI) between 19 and 25 kg/m2 (inclusive) at the screening visit.
- •- The subject has a resting pulse and heart rate (as read on the ECG) between 45 and 100 bpm (inclusive) at the screening visit.
排除标准
- •- The subject has taken any prescription drugs, over-thecounter medications, vitamin supplements, or supplements containing St. John's Wort (Hypericum perforatum) within 2 weeks prior to Day 1.
- •- The subject has a significant history of alcohol abuse, defined as an alcohol intake greater than 21 units per week (A unit of alcohol is defined as 250 mL of lager/beer, 100 mL of wine, or 25 mL of spirits).
- •- The subject has taken any investigational products within 4 months prior to Day 1.
研究者
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