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This Study will evaluate the effects of renal function on pharmacokinetics and safety of DA-8010
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal renal function | Active Comparator | eGFR >=90 mL/min/1.73m^2 |
|
| Mild renal impairment | Experimental | eGFR 60~89 mL/min/1.73m^2 |
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| Moderate renal impairment | Experimental | eGFR 30~59 mL/min/1.73m^2 |
|
| Severe renal impairment | Experimental | eGFR 15~29 mL/min/1.73m^2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-8010 | Drug | DA-8010 5mg single dose administration |
|
| Measure | Description | 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 |
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Inclusion Criteria:
[Healthy Volunteer]
[Renal Impairment Patient]
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Gyeonggi-do | South Korea |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000630740 | DA-8010 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |