Healthy Volunteers
Conditions
Keywords
Dyslipidemia, CKD-519, CETP inhibitor, Food Drug Interaction
Brief summary
The purpose of this study is to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519.
Detailed description
A randomized, open-label, single dose, 1-sequence, 3-treatment, 3-period crossover study to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519 in healthy male subjects.
Interventions
DRUGCKD-519 100mg
DRUGCKD-519 200mg
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
* Between 20 aged and 45 aged in healthy adult male * Body weight more than 50, Body Mass Index between 18 and 29kg/m² * 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 * Those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent
Exclusion criteria
* Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system * Have a acute disease within 28 days before the beginning of study treatment * Have a disease history that can effect drug absorption, distribution, metabolism, excretion * Have a clinically significant chronic disease * Systolic blood pressure\<100mmHg or\>140mmHg, diastolic blood pressure\<60mmHg or\>90mmHg * Defined by the following 12-lead ECG, QTc\>450msec * Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories)) * Subject treated ethical drug within 14 days before the beginning of study treatment * Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment * Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs) * Cannot take standard Meal * Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing * Blood transfusion within 30 days * Taking drugs have received any other investigational drug within 90 days prior to the first dosing * Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days * Continuously taking caffeine(caffeine\>5 cups/day), drinking alcohol(alcohol\>210g/week), smoking excessive cigarettes(cigarette\>10cigarettes/day) * Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasons(for example, noncompliance, a disobliging manner)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vd/F of CKD-519 | 0(predose)~168 |
| Cmax of CKD-519 | 0(predose)~168 |
| AUClast of CKD-519 | 0(predose)~168 |
| Tmax of CKD-519 | 0(predose)~168 |
| AUCinf of CKD-519 | 0(predose)~168 |
| T1/2 of CKD-519 | 0(predose)~168 |
| CL/F of CKD-519 | 0(predose)~168 |
Secondary
| Measure | Time frame |
|---|---|
| Inhibition of CETP(Cholesteryl ester transfer protein) Activity | 0(predose)~168 |
Countries
South Korea
Outcome results
None listed