A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg After Oral Administration in Healthy Male Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- AUCτ,ss
研究概览
简要总结
A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg after Oral Administration 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
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Health Male Volunteers (Age : 19~55 years)
- •Body Weight≥55kg, 18.5≤BMI<25.0
排除标准
- •galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Allergy or Drug hypersensitivity
- •Clinically significant Medical History
- •AST, ALT > Upper Normal Range*1.25, eGFR<60mL/min/1.73㎡
- •Drink during clinical trial period
- •Smoking during clinical trial period
- •Grapefruit/Caffeine intake during clinical trial period
- •No Contraception
研究组 & 干预措施
Group C
Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin
干预措施: Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin (Drug)
Group A
Evogliptin→Evogliptin+Empagliflozin→Empagliflozin
干预措施: Evogliptin→Evogliptin+Empagliflozin→Empagliflozin (Drug)
Group B
Empagliflozin→Evogliptin→Evogliptin+Empagliflozin
干预措施: Empagliflozin→Evogliptin→Evogliptin+Empagliflozin (Drug)
Group D
Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin
干预措施: Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin (Drug)
结局指标
主要结局
AUCτ,ss
时间窗: 4 weeks
area under the concentration-time curve
Cmax,ss
时间窗: 4 weeks
maximum serum concentration
次要结局
未报告次要终点