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| Name | Class |
|---|---|
| Dong Wha Pharmaceutical Co. Ltd. | INDUSTRY |
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The purpose of this study is to compare and explore pharmacokinetics of zabofloxacin, the main component of DW224aa(Test drug) and DW224a(Reference drug).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DW224aa | Experimental | DW224aa given by oral administration |
|
| DW224a | Active Comparator | DW224aa given by oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental DW224aa | Drug | DW224aa tablet, single dose |
| |
| Experimental DW224a |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of zabofloxacin in plasma | Up to 48 | |
| AUClast of zabofloxacin in plasma | Up to 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of zabofloxacin in plasma | Up to 48h | |
| terminal half-life (t1/2) of zabofloxacin in plasma | Up to 48h | |
| CL/F of zabofloxacin in plasma |
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Inclusion Criteria:
a healthy adult male within the range of 20 to 45 years old at the time of screening
one with weight of more than 55kg, in the range of IBW 20%
one who understood completely about this study after the detailed explanation is given, decided to volunteer and gave written informed consent to participate in study in compliance with the requirement of the entire protocol.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung Sang Yu, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Center, Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23865727 | Derived | Han H, Kim SE, Shin KH, Lim C, Lim KS, Yu KS, Cho JY. Comparison of pharmacokinetics between new quinolone antibiotics: the zabofloxacin hydrochloride capsule and the zabofloxacin aspartate tablet. Curr Med Res Opin. 2013 Oct;29(10):1349-55. doi: 10.1185/03007995.2013.825591. Epub 2013 Aug 19. |
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| Drug |
DW224a capsule, single dose |
|
| Up to 48h |