NCT05414591已完成1 期
A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DWP16001 Drug A and DWP16001 Drug B in Healthy Adult Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年5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
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- AUC0_t of DWP16001
研究概览
简要总结
To compare and evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug B 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 adult volunteers aged ≥ 19 years at screening
- •Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
- •Subjects with no congenital or chronic disease that requires treatment, and no clinical symptoms or findings based on medical examination
- •Subjects who are determined eligible to participate in this study based on results of laboratory tests, vital signs, physical examination etc at screening.
排除标准
- •Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
- •Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
- •Clinical laboratory test values are outside the accepted normal range at screening
- •Other exclusive inclusion criteria, as defined in the protocol
研究组 & 干预措施
Sequence group A
Experimental
DWP16001 A mg 1T
干预措施: DWP16001 drug A (Drug)
Sequence group A
Experimental
DWP16001 A mg 1T
干预措施: DWP16001 drug B (Drug)
Sequence group B
Experimental
DWP16001 B mg 3T
干预措施: DWP16001 drug A (Drug)
Sequence group B
Experimental
DWP16001 B mg 3T
干预措施: DWP16001 drug B (Drug)
结局指标
主要结局
AUC0_t of DWP16001
时间窗: 0-72 hours
Area under the plasma concentration versus time curve
Cmax of DWP16001
时间窗: 0-72 hours
Peak Plasma Concetration
次要结局
- Tmax Tmax(0-72 hours)
- AUC of DWP16001(0-72 hours)
- T 1/2 of DWP16001(0-72 hours)
- CL/F of DWP16001(0-72 hours)
- Vd/F of DWP16001(0-72 hours)
研究者
研究点 (1)
Loading locations...
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