A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 5 mg and Metformin IR 1000 mg After Oral Administration in Healthy Male Volunteers
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
- Cmax,ss of DA-1229 and metformin
研究概览
简要总结
This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and Metformin IR 1000 mg after oral administration 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 70-125mg/dL glucose level(at screening)
- •Subject who totally understand 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
- •Subject 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)
- •Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
- •Subject 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 in 1 months currently.
研究组 & 干预措施
D → M → D+M
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: metformin (Drug)
D+M → M → D
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: metformin (Drug)
D → M → D+M
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: DA-1229 (Drug)
D → M → D+M
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: DA-1229 + metformin (Drug)
D → D+M → M
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: DA-1229 (Drug)
D → D+M → M
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: metformin (Drug)
D → D+M → M
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: DA-1229 + metformin (Drug)
M → D → D+M
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: DA-1229 (Drug)
M → D → D+M
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: metformin (Drug)
M → D → D+M
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: DA-1229 + metformin (Drug)
M → D+M → D
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: DA-1229 (Drug)
M → D+M → D
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: metformin (Drug)
M → D+M → D
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: DA-1229 + metformin (Drug)
D+M → M → D
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: DA-1229 (Drug)
D+M → M → D
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: DA-1229 + metformin (Drug)
D+M → D → M
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: DA-1229 (Drug)
D+M → D → M
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: metformin (Drug)
D+M → D → M
D : DA-1229 5mg qd, M : metformin 1000mg bid
干预措施: DA-1229 + metformin (Drug)
结局指标
主要结局
Cmax,ss of DA-1229 and metformin
时间窗: up to 168h
AUCτ,ss of DA-1229 and metformin
时间窗: up to 168h
次要结局
未报告次要终点