Hyperlipidemias
Conditions
Brief summary
Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337 combination
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Between 19 aged and 45 aged in healthy male adult 2. Over 50 kg, BMI between 18.0-29.0 kg/m2 3. Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations. 4. Not abnormal or not clinically significant lab values. 5. Subjects who signed informed consent form with good understandings after explanations by investigators.
Exclusion criteria
1. No history or presence of clinically significant diseases. 2. Subjects showing adverse reaction to investigational product 3. Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption. 4. History of myopathy 5. Subjects with abnormal lab values at least one below 1) AST or ALT\>2 fold of upper normal limit 2) Total bilirubin\>2 fold of upper normal limit 3) CK\>2 fold of upper normal limit 4) Estimated Glomerular filtration rate\<60mL/min/1.73m2 6. Drink over 21 units/week (1 unit= 10g=12.5mL of pure alcohol) or unable to stop drinking during clinical trials 7. Smoke over 10 cigarettes per day or unable to stop smoking 8. Subjects who previously participated in other clinical trials within 90 days 9. Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days 10. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 10 days. 11. Taking medications which induce or block medication metabolism 12. History of drug abuse 13. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days. 14. Disagree to contraception 15. Subjects who are in any conditions impossible participating in the clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0~72hours | To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax |
| AUCt | 0~72hours | To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt |
Countries
South Korea
Outcome results
None listed