A Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010
Renal Impairment, Healthy
About this trial
This is an interventional screening trial for Renal Impairment
Eligibility Criteria
Inclusion Criteria: [Healthy Volunteer] Adult male or female, 19 years to 75 years eGFR ≥ 90 mL/min/1.73m^2 Body weight over 45.0 kg and body mass index in the range of 18.0 to 40.0 kg/m^2 The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate The subjects who are judged appropriate to participate this clinical trial according to the physical examination, laboratory examination and questionnaire [Renal Impairment Patient] Adult male of female, 19 years to 75 years eGFR < 90 mL/min/1.73m^2, not on dialysis Body weight over 45.0 kg and body mass index in the range of 18.0 to 40.0kg/m^2 The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate The subjects who are judged appropriate to participate this clinical trial according to the physical examination, laboratory examination and questionnaire Exclusion Criteria: The subjects with acute illness The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product The subjects hypersensitive to any of the Investigational Product components or other drug components The subjects who have continuously consumed excessive smoking or alcohol within 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization The subjects who have history of drug abuse The subjects who are pregnant or lactating The subjects who do not agree to exclude the possibility of pregnancy using the contraception from the date of the first administration of the Investigational Product until the 4 weeks after the last administration
Sites / Locations
- CHA Bundang Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Normal renal function
Mild renal impairment
Moderate renal impairment
Severe renal impairment
eGFR >=90 mL/min/1.73m^2
eGFR 60~89 mL/min/1.73m^2
eGFR 30~59 mL/min/1.73m^2
eGFR 15~29 mL/min/1.73m^2