NCT07364851尚未招募1 期
A Randomized, Open-label, Single-dose, 2-sequence, Two-period, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW4421-T1 and DW4421S-T1 in Healthy Adult Volunteers
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Safety and pharmacokinetic characteristics evaluation of DW4421-T1 and DW4421S-T1
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult aged 19 to 50 (inclusive) years
- •Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive)
排除标准
- •clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
研究组 & 干预措施
Sequence A
Experimental
cross-over
干预措施: DW4421-T1 (Drug)
Sequence A
Experimental
cross-over
干预措施: DW4421S-T1 (Drug)
Sequence B
Experimental
Cross-over
干预措施: DW4421-T1 (Drug)
Sequence B
Experimental
Cross-over
干预措施: DW4421S-T1 (Drug)
结局指标
主要结局
Cmax
时间窗: up to 48 hour
AUC0-t
时间窗: up to 48 hour
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Enrolling By Invitation
1 期
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DW4421 and DW4421S in Healthy Adult VolunteersNCT07364877Daewon Pharmaceutical Co., Ltd.38
招募中
1 期
Bioequivalence Study for the Safety and the Pharmacokinetics of DWC202313, DWC202314, and DWJ1622 in Healthy Volunteers Under Fed Condition.NCT07267221Daewoong Pharmaceutical Co. LTD.36
招募中
1 期
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1622, DWC202313, and DWC202314 in Healthy Volunteers Under Fasting ConditionsNCT07260851Daewoong Pharmaceutical Co. LTD.40
已完成
1 期
Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics of DW5124 and DW5124-R, and the Effect of Food on DW5124 in Healthy Adult VolunteersNCT07319559Daewon Pharmaceutical Co., Ltd.55
尚未招募
1 期
Evaluate the Safety, Tolerability and Pharmacokinetics of DW5524 in Healthy Adult VolunteersNCT07349589Daewon Pharmaceutical Co., Ltd.48