ACTRN12614000330640已完成1 期
IPX234-B13-01: Evaluation of the Pharmacokinetics and Safety of Dihydroergotamine Administered Via Two Intranasal Delivery Devices in healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 40 Years(—)
- 性别
- All
入选标准
- •Healthy male and female subjects between 18 years and 40 years of age inclusive at the time of Screening
排除标准
- •Presence of a clinically significant disorder including acute or chronic infections, or a malignant neoplasm, and/or involving disease in one or more of these organ systems: cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, dermatologic, hepatic, reproductive, endocrine, or neurologic/psychiatric, as determined by clinical investigators
- •An upper respiratory tract infection or any other acute illness, including active allergic rhinitis, at Screening or at Check-in for each treatment period that the investigator believes may interfere with the administration, nasal retention, or absorption of study drug; or any prior medical conditions that, in the opinion of the Investigator, would interfere or modify the nasal administration, retention, or absorption of study drug
研究者
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