A randomized, open-label, single-dosing, two-treatment, two-sequence, two-period, 2x2 crossover study to evaluate the safety and pharmacokinetics of tadalafil 20 mg tablet and tadalafil 20 mg Oral Dissolving Film in healthy male volunteers

CLPharm0 个研究点目标入组 40 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 19-45
•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. Clinically significant disease with hepatobiliary, nephrological, neurologic, respiratory, haemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
•2. Gastrointestinal disease or gastrointestinal surgery
•3. History of significant hypersensitivity reaction of tadalafil or PDE5 inhibitor drugs
•4. Medical history of organic nitrate administration
•5. Galactose intolerance
•6. Significant cadiac disease history within 6 months
•7. History of Degenerative Retinal Disease hereditarily
•8. Treatment of penile erection with other drug
•9. Subjects with Visual defect by Non-arteritic anterior ischemic optic neuropathy
•10. Drug abuse
•11. Subject treated metabolizing enzyme inducers or inhibitors within 1 month
•12. Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week
•13. Subject treated Investigational product(include Bioequivalence test) within 2 months
•14. Whole blood donation within 2 months, component blood donation or blood transfusion within 1 month
•15. Continuously taking Alcohol > 21 units/week
•16. Cigarette > 10 cigarettes/day
•17. Another clinical condition in judgement of investigator

发起方

CLPharm