None listed
Conditions
Interventions
Drug : 1. Arm A
(1) Period 1 : R
(2) Period 2 : T
(3) Period 3 : TF
2. Arm B
(1) Period 1 : TF
(2) Period 2 : R
(3) Period 3 : T
3. Arm C
(1) Period 1 : T
(2) Period 2 : TF
(3) Period 3 : R
4. Arm D
Sponsors
Korea United Pharm
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast of levodropropizine;Cmax of levodropropizine | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf, T1/2, Tmax of Levodropropizine;Safety evaluation: Adverse event, Vital sign, Physical exam, 12-lead ECG, Laboratory test(CBC, Chemistry, Urine) | — |
Countries
Korea, Republic of
Contacts
Public ContactJangHee Hong
Chungnam National University Hospital
Outcome results
None listed