NCT03769870已完成1 期
A Randomized, Open-label, Cross-over, Multiple Dosing Study to Evaluate Drug-drug Interaction Between Teneligliptin and Atorvastatin in Healthy Male Adults
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
- 30
- 试验地点
- 1
- 主要终点
- Cmax,ss(Maximum concentration at steady state)
研究概览
简要总结
A randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction between Teneligliptin and Atorvastatin in healthy male adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Healthy male adult 19 to 45 years
- •Body weight ≥ 50kg, and BMI between 18-29kg/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
Teneligliptin
Other
干预措施: Teneligliptin 20mg/day (Drug)
Atorvastatin
Other
干预措施: Atorvastatin 40mg/Day (Drug)
Teneligliptin + Atorvastatin
Other
干预措施: Teneligliptin 20mg/day + Atorvastatin 40mg/day (Drug)
结局指标
主要结局
Cmax,ss(Maximum concentration at steady state)
时间窗: 24 hours
AUCτ,ss(Area under the concentration-time curve at steady state)
时间窗: 24hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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