Dyslipidemia
Conditions
Brief summary
Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects.
Detailed description
Open-label, Randomized, 3-period, 6-sequence, crossover study
Interventions
DRUGCKD-519 50mg 2Tabs.
after taking Standard meal, CKD-519 50mg 2Tabs. administration.
DRUGCKD-519 100mg 1Tab.
after taking Standard meal, CKD-519 100mg 1Tab. administration.
DRUGCKD-519 100mg 1Cap.
after taking Standard meal, CKD-519 100mg 1Cap. administration.
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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 11. Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing 12. Blood transfusion within 30 days 13. Taking drugs have received any other investigational drug within 90 days prior to the first dosing 14. Continuously taking caffeine(\>5 cups/day), drinking alcohol(\>30g/day), smoking excessive cigarettes(\>10cigarettes/day) 15. Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasone(for example, noncompliance, a disobliging manner) 16. Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of CKD-519 | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h |
| Tmax of CKD-519 | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h |
| AUClast of CKD-519 | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h |
| AUC0-∞ of CKD-519 | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h |
| t1/2 of CKD-519 | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h |
| CL/F of CKD-519 | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h |
| Vd/F of CKD-519 | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h |
| Emax of CKD-519 CETP(Cholesteryl ester transfer protein) Activity | 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h |
| Tmax of CKD-519 CETP Activity | 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h |
| AUEC of CKD-519 CETP Activity | 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h |
| EC50(half maximal effective concentration ) of CKD-519 CETP Activity | 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h |
Countries
South Korea
Outcome results
None listed