KCT0002383Completed未知
A Randomized, Open-label, Single dose, 3-Treatment, 3-Period Williams-Design to Assess the Pharmacokinetic Characteristics and Food Effect of Levodropropizine Controlled-Release Tablets Compared with Levodropropizine Immediate-Release Tablets in Healthy Male Subjects
Korea United Pharm0 sites48 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 48
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 20(Year) to 55(Year) (—)
- Sex
- Male
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
Investigators
Similar Trials
Recruiting
Not Applicable
A randomized, open-label, single dose, 3-treatment, 3-period, 6-sequence crossover study to investigate the effect of food on the pharmacokinetics/pharmacodynamics and safety of CKD-519 after oral administration in healthy adult volunteersEndocrine, nutritional and metabolic diseaseKCT0001545Chong Kun Dang42
Completed
Not Applicable
A single-dose, 3-treatment, 3-period, 6-sequence crossover study in healthy male subjects to evaluate the pharmacokinetics of GLA5PR GLARS-NF1 tablet 150mg and LYRICA® capsule 75mgEndocrine, nutritional and metabolic diseaseKCT0001311GL PharmTech30
Completed
Not Applicable
A study to compare the pharmacokinetics and safety/tolerability of BS-105 enteric-coated tablet A” or BS-105 enteric-coated tablet B” of Bio-Synectics to original drug in healthy male subjects (Pilot study)Certain infectious and parasitic diseasesKCT0004007Bio-Synectics9
Completed
Not Applicable
A clinical study to compare pharmacokinectic characteristics of Eperisone Hydrochloride and Aceclofenac with HCP1104 treatment to those of co-administration of Eperisone Hydrochloride 50mg tablet and Aceclofenac 100mg tablet in healthy adult male volunteersKCT0000907Hanmi Pharm30
Not yet recruiting
Not Applicable
A randomized, open-label, single dose, three-way crossover clinical trial to investigate the pharmacokinetics incorporating a comparison of fed/fasted pharmacokinetics of HIP1402 in healthy male volunteersDiseases of The genitoruinary systemKCT0001610Hanmi Pharm24