Overview
Compare the Pharmacokinetics and Safety of CKD-391
Status:
Completed
Completed
Trial end date:
2020-01-09
2020-01-09
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
phase I clinical trial to compare the pharmacokinetics and safety of CKD-391 with co-administration of D090 and D337 in healthy adult volunteersPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Chong Kun Dang PharmaceuticalCollaborator:
Seoul National University Bundang Hospital
Criteria
Inclusion Criteria:1. Between 19 aged and 45 aged in healthy male adult
2. 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.
3. Not abnormal or not clinically significant lab values.
4. 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. unable to stop drinking and smoking during clinical trials
6. Subjects who donated whole blood within 60 days or donated component blood within 30
days or received blood transfusion within 30 days
7. History of drug abuse
8. Disagree to contraception
9. Subjects who are in any conditions impossible participating in the clinical trials