NCT07007533已完成1 期
An Open-label, Randomized, Single-dose, Crossover Study to Compare and Evaluate the Safety, Tolerability and Pharmacokinetics Between DA-5223 and DA-5223-R in Healthy Adult Subjects
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
- 38
- 试验地点
- 1
- 主要终点
- AUC0-24h
研究概览
简要总结
This study will compare and evaluate the safety, tolerability and pharmacokinetics between DA-5223 and 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
- Screening
- 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 6 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 A
Experimental
干预措施: DA-5223-R (Drug)
Sequence A
Experimental
干预措施: DA-5223 (Drug)
Sequence B
Experimental
干预措施: DA-5223-R (Drug)
Sequence B
Experimental
干预措施: DA-5223 (Drug)
结局指标
主要结局
AUC0-24h
时间窗: 0~12 hours
Area under the plasma concentration-time curve over the time interval from 0 to 24h
Cmax
时间窗: 0~12 hours
Peak Plasma Concentration
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
Clinical Trial of Comparing DA-5222 Single-administration and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in Healthy Adult SubjectsNCT06993181Dong-A ST Co., Ltd.48
撤回
1 期
A Study to Evaluate the Food Effect on the Pharmacokinetics of DA-5223 in Healthy Adult SubjectsNCT07007520Dong-A ST Co., Ltd.38
Unknown
1 期
Phase 1 Clinical Trial to Evaluate the Safety, PK and PD of DA-5207 TDS in Healthy AdultsHealthyNCT04479865Dong-A ST Co., Ltd.49
已完成
1 期
Phase 1 Clinical Trial of DA-5207 in Healthy AdultsHealthyNCT05127746Dong-A ST Co., Ltd.51
Unknown
1 期
Pharmacokinetics and Safety Profiles After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult VolunteersHealthyNCT05449704Dong-A ST Co., Ltd.90