NCT02385032已完成1 期
Comparative Bioavailability Study of UDCA
Daewoong Pharmaceutical Co. LTD.0 个研究点目标入组 50 人开始时间: 2015年2月最近更新:
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
- 50
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this study is to evaluate bioavailability of two formulations of ursodiol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 19.0 and ≤ 30.0 kg/m
- •No clinically significant findings in a 12-lead electrocardiogram (ECG)
- •Be informed of the nature of the study and give written consent prior to any study procedure
排除标准
- •Known history or presence of any clinically significant medical condition
- •Participated in a clinical trial which involved administration of an investigational medicinal product within 30 days prior to drug administration, or recently participated in a clinical investigation that, in the opinion of the investigator, would jeopardize subject safety or the integrity of the study results
研究组 & 干预措施
AB
Experimental
Ursodiol followed by URSO Forte
干预措施: Ursodiol (Drug)
AB
Experimental
Ursodiol followed by URSO Forte
干预措施: URSO Forte (Drug)
BA
Experimental
URSO Forte followed by Ursodiol
干预措施: Ursodiol (Drug)
BA
Experimental
URSO Forte followed by Ursodiol
干预措施: URSO Forte (Drug)
结局指标
主要结局
Cmax
时间窗: 72 hours
AUClast
时间窗: 72 hours
次要结局
未报告次要终点
研究者
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