NCT07633691已完成1 期
An Open-label, Randomized, Single-dose, Two-Cohort, Two-Period, Crossover Study to Exploratively Evaluate the Safety, Tolerability and Pharmacokinetics of DA-5223 Compared With DA-5223-R in Healthy Adult Subjects
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
This study will exploratively evaluate the safety, tolerability and pharmacokinetics of DA-5223 compared with DA-5223-R in healthy adult subjects
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult male or female, 19 years to 55 years
- •Male weighing 50 kg or more, female weighing 45 kg or more with a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2
- •The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate
排除标准
- •The subjects with acute illness
- •The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product
- •The subjects hypersensitive to any of the Investigational Product components or other drug components
- •The subjects who have continuously consumed excessive smoking or alcohol within 1 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization
- •The subjects who are pregnant or lactating
研究组 & 干预措施
Sequence D
Experimental
干预措施: DA-5223-R (Drug)
Sequence D
Experimental
干预措施: DA-5223-M (Drug)
Sequence C
Experimental
干预措施: DA-5223-R (Drug)
Sequence C
Experimental
干预措施: DA-5223-M (Drug)
Sequence A
Experimental
干预措施: DA-5223-R (Drug)
Sequence A
Experimental
干预措施: DA-5223-F (Drug)
Sequence B
Experimental
干预措施: DA-5223-R (Drug)
Sequence B
Experimental
干预措施: DA-5223-F (Drug)
研究者
研究点 (1)
Loading locations...
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