NCT04830930已完成1 期
A Randomized, Open-label, Single-dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics and Pharmacodynamics of CKD-381 in Healthy Volunteers
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
- 28
- 试验地点
- 1
- 主要终点
- Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose
研究概览
简要总结
A study to investigate the effect of food on the Pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers
详细描述
A randomized, open-label, single-dose, crossover study to investigate the effect of food on the pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 19 aged and 50 aged in healthy adult
- •Body weight more than 55.0kg and body mass index over 18.0kg/m2 and under 30.0kg/m2
- •Have negative result on Helicobacter Pylori antibody test
排除标准
- •Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.
- •Have a gastrointestinal disease history(including surgery) that can effect evaluation of safety, pharmacokinetics and pharmacodynamics of investigational product.
- •Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product, additives or benzimidazole family.
研究组 & 干预措施
Sequence 2
Experimental
Period 1: fed condition/ Period 2: fasted condition
干预措施: CKD-381 (Drug)
Sequence 1
Experimental
Period 1: fasted condition/ Period 2: fed condition
干预措施: CKD-381 (Drug)
结局指标
主要结局
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose
时间窗: 0-24 hours
Cmax
时间窗: 0-24 hours
maximum observed concentration after dose
AUClast
时间窗: 0-24 hours
Area under the plasma concentration versus time curve over the dosing interval after dose
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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