NCT04938752已完成1 期
An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA 2811 in Healthy Subjects
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
- 30
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and DA-2811-R after a single oral dose 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects
- •BMI between 18.5 and 29.9 kg/m2 and weigh at least 50 kg
- •Volunteer who totally understands the progress of this clinical trial, make decision by his or her free will, and signed a consent form to follow the progress
排除标准
- •Volunteer who has present or past history of clinically significant cardiovascular, respiratory, urinary, gastrointestinal, hepatic, renal, skin, immunological, musculoskeletal, endocrinal, neurological, psychiatric and/or hematological disease
研究组 & 干预措施
Sequence I
Experimental
干预措施: DA-2811 (Drug)
Sequence I
Experimental
干预措施: DA-2811-R (Drug)
Sequence II
Experimental
干预措施: DA-2811 (Drug)
Sequence II
Experimental
干预措施: DA-2811-R (Drug)
结局指标
主要结局
AUClast
时间窗: pre-dose~48 hours post-dose
Area under the plasma concentration-time curve from time zero to time the last quantifiable time
Cmax
时间窗: pre-dose~48 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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