NCT03947528Unknown1 期
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年3月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration
研究概览
简要总结
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions
详细描述
To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg after a single oral dose administration in healthy volunteers under fed conditions
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
- 19 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, 19 years of age or older
- •BMI ≥ 18.0 and ≤ 30.0 kg/m
- •Females who participate in this study will be of childbearing or non- childbearing potential
排除标准
- •Know 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
Anpl-one SR Tab. 300mg
Experimental
a single oral dose administration in healthy volunteers under fed condition
干预措施: Sarpogrelate HCL 300mg (Drug)
Sarpodipil SR Tab. 300mg
Active Comparator
a single oral dose administration in healthy volunteers under fed condition
干预措施: Sarpogrelate HCL 300mg (Drug)
结局指标
主要结局
Maximum Plasma Concentration
时间窗: 0~24hours
Maximum Plasma Concentration
Area under the plasma concentration versus time curve
时间窗: 0~24hours
Area under the plasma concentration versus time curve
次要结局
未报告次要终点
研究者
研究点 (1)
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