Status:
COMPLETED
Compare the Pharmacokinetics and Safety of CKD-391
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Collaborating Sponsors:
Seoul National University Bundang Hospital
Conditions:
Hyperlipidemias
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
phase I clinical trial to compare the pharmacokinetics and safety of CKD-391 with co-administration of D090 and D337 in healthy adult volunteers
Eligibility Criteria
Inclusion
- Between 19 aged and 45 aged in healthy male adult
- 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
- unable to stop drinking and smoking during clinical trials
- Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
- History of drug abuse
- Disagree to contraception
- Subjects who are in any conditions impossible participating in the clinical trials
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2020
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04354987
Start Date
October 30 2019
End Date
January 9 2020
Last Update
April 21 2020
Active Locations (1)
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1
Jae-Yong Chung
Gyeonggi-do, Seongnam-si, South Korea, 463-707