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临床试验/KCT0002383
KCT0002383已完成未知

A Randomized, Open-label, Single dose, 3-Treatment, 3-Period Williams-Design to Assess the Pharmacokinetic Characteristics and Food Effect of Levodropropizine Controlled-Release Tablets Compared with Levodropropizine Immediate-Release Tablets in Healthy Male Subjects

Korea United Pharm0 个研究点目标入组 48 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
48

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 55(Year)(—)
性别
Male

入选标准

  • 1. Healthy male volunteer in the age of 20-55
  • 2. Body weight = 55 kg and in the range of calculated IBW(Ideal Body Weight) ±20%
  • 3. Subject without a hereditary problems, chronic disease and morbid symptom
  • 4. Suitable clinical laboratory test values
  • 5. Subject who sign on an informed consent form willingly

排除标准

  • 1. History of significant hypersensitivity reaction of levodropropizine or anti-tussive drugs
  • 2. Sitting systolic blood pressure = 145 mmHg or< 95 mmHg, sitting diastolic blood pressure = 100 mmHg or < 50 mmHg, pulse = 100 beats per minute
  • 3. Clinically significant disease with hepatobiliary, nephrological, neurologic, respiratory, haemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
  • 4. Galactose intolerance
  • 5. Significant cardiac arrhythmia, QT prolongation (>450 m/sec)
  • 6. Gastrointestinal disease or gastrointestinal surgery
  • 7. Medical history gastric ulcer or gastric hemorrhage within 2 months
  • 8. Continuously taking Alcohol > 21 units/week, Cigarette > 10 cigarettes/day
  • 9. Subject treated Investigational product(include Bioequivalence test) within 3 months
  • 10. Whole blood donation within 2 months, component blood donation or blood transfusion within 1 month
  • 11. Subject treated metabolizing enzyme inducers or inhibitors within 1 month
  • 12. Subject treated ethical the counter or herbal medicine within 2 weeks, weeks, over-the-counter or vitamin within 1 week
  • 13. Psychological disease, alcoholism
  • 14. Another clinical condition in judgement of investigator
  • 15. Subject treated grapefruit juice within 1 week
  • 16. Drug abuse

研究者

发起方
Korea United Pharm

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