NCT05108571已完成1 期
An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5210 10/1000mg in Healthy Subjects at Fasting State
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
- 40
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Phamacokinetics and safety profiles of DA-5210 10/1000mg in Healthy subjects at Fasting State
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 Volunteers
- •BMI between 18 and 30 kg/m2
- •Body weight : Male≥50kg, Female≥45kg
排除标准
- •Allergy or Drug hypersensitivity
- •Clinically significant Medical History
研究组 & 干预措施
Sequence A
Experimental
干预措施: DA-5210 10/1000mg (Drug)
Sequence A
Experimental
干预措施: DA-5210-R 10/1000mg (Drug)
Sequence B
Experimental
干预措施: DA-5210 10/1000mg (Drug)
Sequence B
Experimental
干预措施: DA-5210-R 10/1000mg (Drug)
结局指标
主要结局
Cmax
时间窗: pre-dose~48 hours post-dose
maximum plasma concentration
AUCt
时间窗: pre-dose~48 hours post-dose
area under the curve
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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