NCT05181007已完成1 期
An Open-label, Two-stage Study Evaluating Drug-drug Interaction Between Ciprofol Injectable Emulsion and Mefanamic Acid or Valproate in Healthy Volunteers
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2021年12月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- effect of mefanamic acid on the Cmax of ciprofol
研究概览
简要总结
study the effect of mefanamic acid or valproate on ciprofol
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal results of physical examination, laboratory tests (blood routine, blood biochemistry, and urine routine), and 12-lead ECG, or considered by the investigator to be clinically insignificant abnormalities; no significant potential difficult airway (modified Mallampati score Class I-II);
- •No previous history of primary diseases in major organs, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no history of malignant hyperthermia and other hereditary disorders; no history of mental/neurological disorders; no history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
- •Understand procedures and methods of this trial, willing to sign the informed consent form and comply strictly with the clinical trial protocol to complete this study.
排除标准
- •Known allergies to excipients of ciprofol injectable emulsion (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide), mefanamic acid, or valproate, or having contraindications to ciprofol/mefanamic acid/valproate; a history of drug allergies (including anesthetics), allergies, or prone to allergies;
研究组 & 干预措施
MFA
Active Comparator
mefanamic acid
干预措施: Mefanamic Acid (Drug)
VPA
Active Comparator
valproate
干预措施: Valproate (Drug)
结局指标
主要结局
effect of mefanamic acid on the Cmax of ciprofol
时间窗: 0-24hour post ciprofol dosing
Peak Plasma Concentration (Cmax)
effect of mefanamic acid on the AUC of ciprofol
时间窗: 0-24hour post ciprofol dosing
Area under the plasma concentration versus time curve (AUC)
effect of valproate on the Cmax of ciprofol
时间窗: 0-24hour post ciprofol dosing
Peak Plasma Concentration (Cmax)
effect of valproate on the AUC of ciprofol
时间窗: 0-24hour post ciprofol dosing
Area under the plasma concentration versus time curve (AUC)
次要结局
- Safety when ciprofol is co-administered with mefanamic acid or valproate(0-24hour post ciprofol dosing)
- effect of mefanamic acid or valproate on the MOAA/S of ciprofol(0-24hour post ciprofol dosing)
- effect of mefanamic acid or valproate on the BIS of ciprofol(0-24hour post ciprofol dosing)
研究者
研究点 (1)
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