The Pharmacokinetic Characteristics and Food Effect of Levodropropizine Controlled-Release Tablets Compared with Levodropropizine Immediate-Release Tablets

Not Applicable

Completed

• Conditions: Diseases of th respiratory system

• Registration Number: KCT0002383
• Lead Sponsor: Korea United Pharm

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: 48

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
AUClast of levodropropizine;Cmax of levodropropizine

Secondary Outcome Measures

Name	Time	Method
AUCinf, T1/2, Tmax of Levodropropizine;Safety evaluation: Adverse event, Vital sign, Physical exam, 12-lead ECG, Laboratory test(CBC, Chemistry, Urine)