KCT0001729
Active, not recruiting
未知
Clinical trial to assess the pharmacokinetic/Pharmacodynamic characteristics and safety/tolerability of CKD-519 new formulation in healthy male subjects
Chong Kun Dang0 sites30 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Endocrine, nutritional and metabolic disease
- Sponsor
- Chong Kun Dang
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Between 20 aged and 45 aged in healthy male adult
- •2\.Body weight \= 50kg and in the range of calculated BMI(Body Mass Index) 18\~29kg/m2
- •3\.Subject who sign on an informed consent form willingly
- •4\.Necessarily he agrees that use double contraceptions and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
Exclusion Criteria
- •1\.Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system
- •2\.Have a acute disease within 28 days before the beginning of study treatment
- •3\.Have a disease history that can effect drug absorption, distribution, metabolism, excretion
- •4\.Have a clinically significant chronic disease
- •5\.Systolic blood pressure \<100mmHg or \>140mmHg, diastolic blood pressure\<60mmHg or \>90mmHg
- •6\.Positive for serology test (HBsAg, anti\-HCV Ab, anti\-HIV Ab, VDRL(Venereal Disease Research Laboratories))
- •7\.Subject treated ethical drug within 14 days before the beginning of study treatment
- •8\.Subject treated over\-the\-counter or herbal medicine within 7 days before the beginning of study treatment
- •9\.Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs)
- •10\.Cannot take standard Meal
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
Pharmacokinetic drug interaction between celecoxib and rebamipideNot ApplicableKCT0000381Hanlim Pharmaceutical30
Recruiting
Not Applicable
Clinical trial to assess the pharmacokinetic characteristics of Lodivixx tab. 5/160mg in healthy male subjectsDiseases of the circulatory systemKCT0000710Hanlim Pharmaceutical60
Recruiting
Not Applicable
Clinical trial to assess the pharmacokinetic characteristics of Lodivixx tab. 5/160mg in healthy male subjectsDiseases of the circulatory systemKCT0000489Hanlim Pharmaceutical40
Active, not recruiting
Not Applicable
The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin CaDiseases of the circulatory systemKCT0001258Hanlim Pharmaceutical40
Completed
Not Applicable
A Study to Evaluate the Safety and Pharmacokinetics of NVP-1402KCT0003213avipharm38