临床试验/NCT04272502

NCT04272502已完成1 期

Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 in Healthy Adult Volunteers

Chong Kun Dang Pharmaceutical1 个研究点分布在 1 个国家目标入组 15 人开始时间: 2019年6月4日最近更新: 2020年2月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Chong Kun Dang Pharmaceutical
入组人数: 15
试验地点: 1
主要终点: Cmax

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D326 and D337 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 45 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•19 ≤ age ≤ 45
•Health Volunteers
•Subject who agreeds to participate in this clinical trial voluntarily

排除标准

•Subject who cannot participate in a clinical trial based on the PI's judgment

研究组 & 干预措施

Sequence C

Experimental

CKD-828, D326, D337, CKD-F1, CKD-F2

干预措施: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337 (Drug)

Sequence A

Experimental

CKD-828, D326, D337, CKD-F1, CKD-F2

干预措施: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337 (Drug)

Sequence B

Experimental

CKD-828, D326, D337, CKD-F1, CKD-F2

干预措施: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337 (Drug)

结局指标

主要结局

Cmax

时间窗: 0 hour ~ 144 hour

Maximum plasma concentration of the drug

AUCt

时间窗: 0 hour ~ 144 hour

Area under the concentration-time curve from time zero to time

次要结局

未报告次要终点

研究者

发起方

Chong Kun Dang Pharmaceutical

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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