NCT01271257已完成1 期
Phase 1 Study of Titrated Oral Misoprostol
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- AUC480 (the area under the curve of serum concentration of misoprostol acid against time up to 480 minutes)
研究概览
简要总结
The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional oral misoprostol.
详细描述
The primary outcomes measures of the study are the area under the curve of serum concentration of misoprostol acid against time up to 240, 360 and 480 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •20-40 Y/O healthy and non-pregnant woman
排除标准
- •heart, liver or kidney disease, anaphylaxis to misoprostol
研究组 & 干预措施
hourly misoprostol
Experimental
20 microgram misoprostol intake per hour
干预措施: Misoprostol (Drug)
traditional misoprostol
Active Comparator
80 microgram misoprostol intake per 4 hours
干预措施: Misoprostol (Drug)
结局指标
主要结局
AUC480 (the area under the curve of serum concentration of misoprostol acid against time up to 480 minutes)
时间窗: 480 min post start of oral misoprostol administration
次要结局
- AUC360 (the area under the curve of serum concentration of misoprostol acid against time up to 360 minutes)(360 min post start of oral misoprostol administration)
- AUC240 (the area under the curve of serum concentration of misoprostol acid against time up to 240 minutes)(240 min post start of oral misoprostol administration)
研究者
Shi-Yann Cheng
Director of Department of Obstetrics and Gynecology
China Medical University Hospital
研究点 (1)
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