Status:
COMPLETED
Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Hyperlipidemias
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337 combination
Eligibility Criteria
Inclusion
- Between 19 aged and 45 aged in healthy male adult
- Over 50 kg, BMI between 18.0-29.0 kg/m2
- 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.
- Not abnormal or not clinically significant lab values.
- Subjects who signed informed consent form with good understandings after explanations by investigators.
Exclusion
- No history or presence of clinically significant diseases.
- Subjects showing adverse reaction to investigational product
- Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
- History of myopathy
- 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
- Drink over 21 units/week (1 unit= 10g=12.5mL of pure alcohol) or unable to stop drinking during clinical trials
- Smoke over 10 cigarettes per day or unable to stop smoking
- Subjects who previously participated in other clinical trials within 90 days
- Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
- Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 10 days.
- Taking medications which induce or block medication metabolism
- History of drug abuse
- Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
- Disagree to contraception
- Subjects who are in any conditions impossible participating in the clinical trials
Key Trial Info
Start Date :
September 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2018
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03793985
Start Date
September 5 2018
End Date
November 13 2018
Last Update
January 7 2019
Active Locations (1)
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1
INHA University Hospital
Incheon, South Korea