Healthy, Renal Impairment
Conditions
Brief summary
This Study will evaluate the effects of renal function on pharmacokinetics and safety of DA-8010
Interventions
DRUGDA-8010
DA-8010 5mg single dose administration
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUClast) of DA-8010 | Pre-dose, 1hour, 2hour, 3hour, 3.5hour, 4hour, 4.5hour, 5hour, 5.5hour, 6hour, 6.5hour, 7hour, 8hour, 12hour, 24hour, 48hour post-dosing on Day 1 |
| Peak Plasma Concentration (Cmax) of DA-8010 | Pre-dose, 1hour, 2hour, 3hour, 3.5hour, 4hour, 4.5hour, 5hour, 5.5hour, 6hour, 6.5hour, 7hour, 8hour, 12hour, 24hour, 48hour post-dosing on Day 1 |
Countries
South Korea
Outcome results
None listed