NCT05132049已完成1 期
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DA-5211 and Co-administration of DA-5211-R1 and DA-5211-R2 in Healthy Adult Volunteer
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
- 42
- 试验地点
- 1
- 主要终点
- AUCt
研究概览
简要总结
Pharmacokinetics and safety Profiles after administration of DA-5211 and co-administration of DA-5211-R1 and DA-5211-R2 in healthy adult 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 —（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
- •Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study
排除标准
- •Subjects with allergy or drug hypersensitivity
- •Subjects with clinically significant medical history
- •Subjects with history of drug abuse or addicted
研究组 & 干预措施
Sequence A
Experimental
干预措施: DA-5211 (Drug)
Sequence A
Experimental
干预措施: DA-5211-R1 + DA-5211-R2 (Drug)
Sequence B
Experimental
干预措施: DA-5211 (Drug)
Sequence B
Experimental
干预措施: DA-5211-R1 + DA-5211-R2 (Drug)
结局指标
主要结局
AUCt
时间窗: pre-dose~72 hours post-dose
area under the curve
Cmax
时间窗: pre-dose~72 hours post-dose
maximum plasma concentration
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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