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
- Handok Inc.
- 入组人数
- 26
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
An open label, one sequence study to investigate the pharmacokinetic drug interaction between Teneligliptin and Glimepiride in healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male adult aged 20 to 45 years
- •Body weight ≥ 50kg, and BMI between 18 and 29 kg/m2 at screening
- •Subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose.
- •Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.
排除标准
- 未提供
研究组 & 干预措施
single arm
Experimental
干预措施: Teneligliptin+Glimepiride (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 24hr
Area under the plasma concentration versus time curve (AUC)
时间窗: 24hr
次要结局
未报告次要终点
研究者
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