NCT04874129Unknown1 期
Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506
Yooyoung Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters: Cmax
研究概览
简要总结
To evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A
详细描述
Phase 1 to evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A. Which is designed as ramdomized, oral, single dose, two-way crossover.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Over 19 ages healthy men
- •Over 50.0kg, 18.0kg/m2 ≤ BMI ≤ 30.0kg/m2
- •Men who don't 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 caffeine within 24 hours before. etc.
研究组 & 干预措施
A Group
Other
Two-way Crossover
干预措施: YYC506-T and YYC506-A (phase 1) (Drug)
A Group
Other
Two-way Crossover
干预措施: YYC506 (phase 2) (Drug)
B Group
Other
Two-way Crossover
干预措施: YYC506 (phase 1) (Drug)
B Group
Other
Two-way Crossover
干预措施: YYC506-T and YYC506-A (phase 2) (Drug)
结局指标
主要结局
Pharmacokinetic parameters: Cmax
时间窗: Until 48 hours
Cmax
Pharmacokinetic parameters: AUC
时间窗: Until 48 hours
YYC506-T, YYC506-A, YYC506 AUC
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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