NCT05797922招募中1 期
A Phase 1 Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics and Safety of DWP16001 After Administration in Healthy Adult Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年3月9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
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cmax of DWP16001
研究概览
简要总结
This study aims to evaluate the effect of food on the pharmacokinetics and safety of DWP16001 after oral administration.
详细描述
The study design is A randomized, Open-label, Oral, Single-dose, Two-way crossover study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •A person who has decided to participate voluntarily and agreed in writing prior to the screening procedure after understanding the detailed explanation of this clinical trial.
- •A person who is 19 years of age or more at the time of screening.
- •Those with a weight of 50.0 kg or more and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.
排除标准
- •A person who has a genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •A person who has a history of gastrointestinal surgery/disease, such as Crohn's disease, ulcer, acute or chronic pancreatitis, which may affect the absorption of drug for clinical trials. (Except for simple appendectomy or hernia surgery)
研究组 & 干预措施
DWP16001 to Group A
Experimental
Group A: Fasting in Period 1 / Fed in Period 2
干预措施: DWP16001 (Drug)
DWP16001 to Group B
Experimental
Group B: Fed in Period 1 / Fasting in Period 2
干预措施: DWP16001 (Drug)
结局指标
主要结局
Cmax of DWP16001
时间窗: 0 to 72 hours
Cmax of DWP16001
AUC0-t of DWP16001
时间窗: 0 to 72 hours
AUC0-t of DWP16001
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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