NCT04874142已完成1 期
Phase 1 to Evaluate the Safety and Pharmacokinetic Durg-drug Interaction of YYC506-T and YYC506-A
Yooyoung Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年11月20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
- 48
- 试验地点
- 1
- 主要终点
- Pharmacokietic parameters administration: Cmax
研究概览
简要总结
To evaluate the safety and pharmacokinetics drug-drug interaction of YYC506-T and YYC506-A
详细描述
Phase 1 to evaluate the safety and pharmacokinetics drug-drug interaction of YYC506-T and YYC506-A. Which is designed as two cohort, single-sequence, paralle, open label, multiple oral dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Over 19 ages healty men
- •Over 50.0kg, 18.0kg/m2 ≤ BMI ≤30.0kg/m2
- •Men who dont have congenital disease and other cronic disease need to be cared etc.
排除标准
- •Men who have congenital liver disease (AST, ALT, CK ≥ 2X ULN)
- •Men who have drunken or eatten something including carffeine within 24 hours before etc.
研究组 & 干预措施
A Group
Experimental
Two cohort, single sequence
干预措施: YYC506-T (Drug)
A Group
Experimental
Two cohort, single sequence
干预措施: YYC506-T + YYC506-A (Drug)
B Group
Experimental
Two cohort, single sequence
干预措施: YYC506-A (Drug)
B Group
Experimental
Two cohort, single sequence
干预措施: YYC506-A + YYC506-T (Drug)
结局指标
主要结局
Pharmacokietic parameters administration: Cmax
时间窗: Until 48 hours
YYC506-T, YYC506-A, and concomitant administration Cmax
Pharmacokietic parameters administration: AUC
时间窗: Until 48 hours
YYC506-T, YYC506-A, and concomitant administration AUC
次要结局
未报告次要终点
研究者
研究点 (1)
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