ACTRN12622000952741已完成1 期
An open label, four-way crossover study to evaluate the pharmacokinetic effects of different dosages of a novel sublingual dexmedetomidine wafer compared to intravenous dexmedetomidine, in healthy volunteers under fasted conditions.
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1.Good general health.
- •2..Willing and able to provide informed consent for study participation.
- •3.Has suitable venous access for blood sampling.
- •4.Body weight a minimum of 50 kg and BMI within the range of 19.0-28.0 kg/m2 (inclusive).
排除标准
- •1.History of or current serious, clinically significant, or unstable medical condition which, in the opinion of the Investigator, could affect safety or integrity of study results.
- •2.Presence or history of malignancy (exception: successfully treated basal cell carcinoma is not an exclusion).
- •3.Clinically significant abnormal 12-lead ECG or history of clinically significant cardiac dysrhythmias, including bradycardia.
- •4.Clinically significant orthostatic vital signs at screening or vital signs on admission day.
研究者
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