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This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic parameters of DA-8031 as well as safety profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-8031 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-8031 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetic parameters such as AUC(Area under concentration-time curve), Cmax, Tmax, T1/2, fe, and CL/F of DA-8031 by as assessment of plasma and urine concentration |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerance of DA-8031 by assessment of vital signs, clinical laboratory tests, physical examinations, ECG findings, and adverse events collected by investigator questionnaire and subjects spontaneous report |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Institute, Seoul National University Hospital | Seoul | Chongno-Gu, Yon-Gon Dong 28 | 110-744 | South Korea |
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| ID | Term |
|---|---|
| C559089 | DA 8031 |
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