A Randomized, Open-label, Crossover, Single Dose Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 5/1000 mg) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 After Single Oral Administration in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Maximum of concentration (Cmax) of Evogliptin and Metformin
研究概览
简要总结
This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01 and to investigate the effect of food on the pharmacokinetics of DA-1229_01 in healthy male volunteers
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 20 to 45, healthy male subjects(at screening)
- •Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
- •FPG 60-125mg/dL glucose level(at screening)
- •Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
排除标准
- •Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
- •Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
- •Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction
- •Subject who already participated in other trials in 2 months
- •Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
研究组 & 干预措施
(Part 1) DA-1229_01 → E+M
DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg
干预措施: DA-1229_01 (Drug)
(Part 1) DA-1229_01 → E+M
DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg
干预措施: E+M (Drug)
(Part 1) E+M → DA-1229_01
DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg
干预措施: DA-1229_01 (Drug)
(Part 1) E+M → DA-1229_01
DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg
干预措施: E+M (Drug)
(Part 2) DA-1229_01 fast → fed
DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet
干预措施: DA-1229_01 fast (Drug)
(Part 2) DA-1229_01 fast → fed
DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet
干预措施: DA-1229_01 fed (Drug)
DA-1229_01 fed → fast
DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet
干预措施: DA-1229_01 fast (Drug)
DA-1229_01 fed → fast
DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet
干预措施: DA-1229_01 fed (Drug)
结局指标
主要结局
Maximum of concentration (Cmax) of Evogliptin and Metformin
时间窗: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Area Under Curve(AUC)last of Evogliptin and Metformin
时间窗: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
次要结局
- Area Under Curve(AUC)inf of Evogliptin and Metformin(1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose)
- Time prior to the first measurable concentration (tlag) of Metformin (only in Part 2 trial)(1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose)
- Apparent Clearance(CL/F) of Evogliptin and Metformin(1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose)
- Time of maximum concentration(Tmax) of Evogliptin and Metformin(1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose)
- Terminal half-life(t1/2) of Evogliptin and Metformin(1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose)