To Compare the Safety and PK/PD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function
Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria: A person who has decided to participate voluntarily and agreed in writing prior to the screening procedure after understanding the detailed explanation of this clinical trial. A person who is 19 years of age or more and under 80 years of age at the time of screening. Those with a weight of 45.0 kg or more and 90.0 kg or less and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less. Exclusion Criteria: A person who has a history of gastrointestinal diseases (e.g., ulcer, inflammatory bowel disease, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of DWP16001. Those who are hypersensitive to drugs and other drugs (aspirin, antibiotics, etc.) including the SGLT2 inhibitor family or who have a history of clinically significant hypersensitivity reaction. Serum Cr >1.5mg/dL or eGFR (CKD-EPI Cr) <60mL/min/1.73m2 Those who have used SGLT2 inhibitor family drugs within two weeks of the scheduled date of administration of DWP16001.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
DWP16001 to normal haptic function
DWP16001 to Child-Pugh Class A
DWP16001 to Child-Pugh Class B
Normal hepatic function
Child-Pugh Class A
Child-Pugh Class B