A Randomized, Open-label, Single Dose, 2-period, 2-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-379 and Coadministration of D759, D745 and D150 in Healthy Subjects

A125_02BE2226

A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination

2023-02-27

2023-03-23

2023-04-10

Completed

Early phase I

32

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

2023-05-11