NCT03512821已完成1 期
A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fed Conditions
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2017年10月1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
- 77
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions
详细描述
A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Healthy, non-smoking, male and female subjects, 18 years of age or older
- •BMI ≥ 19.0 and ≤ 30.0 kg/m
- •Females who participate in this study will be of chilbearing or nonchildbearing potential
排除标准
- •Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results
研究组 & 干预措施
Urso Forte 500mg tablets
Active Comparator
Urso forte 500mg tablets followed by Ursodiol 500mg tablets
干预措施: Urso Forte 500Mg Tablet (Drug)
Ursodiol 500mg tablets
Experimental
Ursodiol 500mg tablets followed by Urso Forte 500mg tablets
干预措施: Ursodiol 500 MG (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: 0-72hours
Maximum Plasma Concentration (Cmax)
时间窗: 0-72hours
次要结局
未报告次要终点
研究者
研究点 (1)
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