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: 2019年3月11日

适应症

试验速览

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•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

•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

发起方

Korea United Pharm