KCT0001692已完成未知
A randomized, open-label, crossover, single dose clinical trial to investigate safety/tolerability and pharmacokinetics of DA-1229_01 (Evogliptin/Metformin XR 2.5/500 mg x 2 tablets) compared to co-administration of Evogliptin 5 mg and Metformin XR 1000 mg after single oral administration in healthy male volunteers
Dong-A ST0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 45(Year)（—）
- 性别
- Male
入选标准
- •Age between 19 to 45, healthy male subjects(at screening)
- •Body weight between 55kg - 90kg, BMI(Body Mass Index) between 18.0 - 27.0
- •FPG (Fasting Plasma Glycose) 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
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 Gastrointestinal(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 or bioequivalence(BE) studies in 3 months
- •Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
研究者
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