the safety and pharmacokinetics of tadalafil 20 mg tablet and tadalafil 20 mg Oral Dissolving Film in healthy male volunteers

Not Applicable

Completed

• Conditions: Diseases of The genitoruinary system

• Registration Number: KCT0002360
• Lead Sponsor: CLPharm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUClast of tadalafil;Cmax of tadalafil

Secondary Outcome Measures

Name	Time	Method
AUCinf, tmax, t1/2ß, CL/F of tadalafil