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临床试验/KCT0001173
KCT0001173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 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

Dong-A ST0 个研究点目标入组 64 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
64

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
20(Year) 至 45(Year)(—)
性别
Male

入选标准

  • •Age between 20 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 in 2 months
  • •Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

研究者

发起方
Dong-A ST

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