A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg after oral administration in healthy male subjects
详细描述
A randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence, crossover study
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Male Volunteers (Age: 19~45years)
- •55<Body Weight<90, 18<BMI<27
- •FPG: 70-125 mg/dL
排除标准
- •galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Clinically significant Medical History
- •Allergy or Drug Hypersensitivity
- •AST(SGOT), ALT(SGPT) > Upper Normal Range*1.5, eGFR<80 mL/min
- •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
A group
Evogliptin Pioglitazone Evogliptin+Pioglitazone
干预措施: Evogliptin, Pioglitazone, Evogliptin+Pioglitazone (Drug)
B group
Pioglitazone Evogliptin Evogliptin+Pioglitazone
干预措施: Pioglitazone, Evogliptin, Evogliptin+Pioglitazone (Drug)
C group
Evogliptin Evogliptin+Pioglitazone Pioglitazone
干预措施: Evogliptin, Evogliptin+Pioglitazone, Pioglitazone (Drug)
D group
Pioglitazone Evogliptin+Pioglitazone Evogliptin
干预措施: Pioglitazone, Evogliptin+Pioglitazone, Evogliptin (Drug)
E group
Evogliptin+Pioglitazone Evogliptin Pioglitazone
干预措施: Evogliptin+Pioglitazone, Evogliptin, Pioglitazone (Drug)
F group
Evogliptin+Pioglitazone Pioglitazone Evogliptin
干预措施: Evogliptin+Pioglitazone, Pioglitazone, Evogliptin (Drug)
结局指标
主要结局
AUC
时间窗: 1d~6d pre-dose, 15d~20d pre-dose, 29~34d pre-dose, 7d/21d/35d pre-dose and post-dose
area under the concentration-time curve
次要结局
未报告次要终点