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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0002360

Enrollment

Registered

2017-06-15

Start date

2014-10-02

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1. Arm A (1) Period 1: Tadalafil 20 mg, PO,1 day administration (2) Period 2: CLP0314 (Tadalafil 20 mg ODF) 20 mg, PO, 1 day administration 2. Arm B (1) Period 1: CLP0314 (Tadalafil 20 mg

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
AUClast of tadalafil;Cmax of tadalafil	—

Secondary

Measure	Time frame
AUCinf, tmax, t1/2ß, CL/F of tadalafil	—

Countries

Korea, Republic of

Contacts

Public ContactJang Hee Hong

Chungnam National University Hospital

boniii@naver.com+82-42-280-6940

Outcome results