Overview
Pharmacokinetics and Safety/Tolerability of CKD-379
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2023-04-13
2023-04-13
Target enrollment:
0
0
Participant gender:
All
All
Summary
A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combinationPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Criteria
Inclusion Criteria:- Between 19 aged and 50 aged in healthy adult
- 50.0kg≤Body weight≤90.0kg and 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2
Exclusion Criteria:
- Have clinical significant medical history or disease that hepatobiliary system,
kidney, nervous system, immune system, respiratory system, digestive system, urinary
system, endocrine system(Type I or Type II Diabetes Mellitus, diabetic ketoacidosis
etc.), hematological system, cardiovascular system(heart failure, Torsades de pointes
etc.), mental illness
- Have clinical significant medical history or disease that urinary tract infection or
genital infection including urosepsis, pyelonephritis
- Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect
drug absorption or surgery
- Those who are pregnant or breastfeeding
- Those who are deemed inappropriate to participate in clinical trial by investigators