NL-OMON49143已完成不适用
Pharmacokinetic and pharmacodynamic profile of midazolam intranasal spray in elderly volunteers. - CS0314 Midazolam
QPS Netherlands B.V.0 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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 99（—）
入选标准
- •1. Adult, men and women (of non-childbearing potential), aged from 65 to 90
- •years old (both inclusive).
- •2. Body Mass Index (BMI) * 18 and * 30 kg/m², inclusive, and a total body
- •weight >50 kg, at screening and check-in.
- •3. American Society of Anesthesiologists (ASA) Physical Status 1 or 2
- •4. Understand the study procedures in the informed consent form(s) (ICF(s)),
- •and be willing and able to comply with the protocol.
排除标准
- •1. Current use of midazolam
- •2. Contraindications for the use of midazolam
- •3. History or presence of significant cardiovascular disease (ASA >2), or
- •significant cardiovascular disease risk factors, significant coronary artery
- •disease, or any known genetic pre disposition to cardiac arrhythmia (including
- •long QT syndrome.)
- •4. History or presence of significant (ASA >2) pulmonary, hepatic, renal,
- •hematological, gastrointestinal, endocrine, immunologic, dermatologic,
- •neurological (inclusive of any seizure disorder), or psychiatric disease.
研究者
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