NCT05954247尚未招募1 期
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers Under Fasting Conditions
Daewoong Pharmaceutical Co. LTD.0 个研究点目标入组 24 人开始时间: 2023年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Area under the curve from the time of dosing to the last measurable concentration(AUClast) of DWJ1543
研究概览
简要总结
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1543 in healty adult volunteers.
详细描述
The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.
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
- 否
入选标准
- •Over 19 year old
- •Healthy adult volunteers
排除标准
- •Eye disorders including cataracts
- •Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders
研究组 & 干预措施
Intervention: DWJ1543
Experimental
干预措施: DWJ1543 (Drug)
Intervention: DWC202216
Experimental
干预措施: DWC202216 (Drug)
结局指标
主要结局
Area under the curve from the time of dosing to the last measurable concentration(AUClast) of DWJ1543
时间窗: At pre-dose (0 hour), and post-dose 1 to 120 hour.
Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543
时间窗: At pre-dose (0 hour), and post-dose 1 to 120 hour.
次要结局
未报告次要终点
研究者
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