Bioequivalence Study of Methacholine for Inhalation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peak Concentration
研究概览
简要总结
This trial was divided into two parts. The first part was the PK bioequivalence study in healthy people, which was designed as a single-dose, randomized, open, four-cycle, two-sequence, fully repeated crossover design, and planned to enroll 20 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Test preparation：Methylcholine chloroacetate for inhalation
Inhale methacholine solution for 1 minute
干预措施: Test preparation：Methylcholine chloroacetate for inhalation (Drug)
Reference preparation：Methylcholine chloroacetate for inhalation（(Provocholin）
Inhale methacholine solution for 1 minute
干预措施: Reference preparation：Methylcholine chloroacetate for inhalation（(Provocholin） (Drug)
结局指标
主要结局
Peak Concentration
时间窗: Within 60 minutes before administration and within 3 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 6 hours, and 8 hours after administration
The highest plasma drug concentration that can be achieved after administration
The area under the blood concentration time curve when the time is from 0 to the last time point selected（AUC0-t）
时间窗: Within 60 minutes before administration and within 3 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 6 hours, and 8 hours after administration
The area under the blood concentration time curve from 0 to t after administration
The area under the blood concentration time curve during time from 0 to infinity（AUC0-∞）
时间窗: Within 60 minutes before administration and within 3 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 6 hours, and 8 hours after administration
Area under the blood concentration time curve after medication
次要结局
未报告次要终点
研究者
Ting YANG
Principal Investigator
China-Japan Friendship Hospital