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NCT01341249

Clinical Trial to Compare the Pharmacokinetic Profiles of DW224aa (Aspartate) Tablet and DW224a (Hydrochloride) Capsule After a Single Oral Administration in Healthy Male Volunteers

Completed Phase 1 Last updated 15 July 2011
What this trial tests

Phase 1 trial testing Experimental DW224aa in Healthy in 32 participants. Completed.

Timeline
1 April 2011
Primary endpoint
1 May 2011

Quick facts

Lead sponsorSeoul National University Hospital
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Enrollment32
Start date1 April 2011
Primary completion1 May 2011
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Seoul National University Hospital

Who can join

Adults 20 to 45, male only, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The purpose of this study is to compare and explore pharmacokinetics of zabofloxacin, the main component of DW224aa(Test drug) and DW224a(Reference drug).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Delafloxacin, Finafloxacin, and Zabofloxacin: Novel Fluoroquinolones in the Antibiotic Pipeline.
    Kocsis B, Gulyás D, Szabó D. · · 2021 · cited 35× · PMID 34943718 · DOI 10.3390/antibiotics10121506
  2. Emerging Treatment Options for Infections by Multidrug-Resistant Gram-Positive Microorganisms.
    Koulenti D, Xu E, Song A, Sum Mok IY, et al · · 2020 · cited 27× · PMID 32019171 · DOI 10.3390/microorganisms8020191
  3. Comparison of pharmacokinetics between new quinolone antibiotics: the zabofloxacin hydrochloride capsule and the zabofloxacin aspartate tablet.
    Han H, Kim SE, Shin KH, Lim C, et al · · 2013 · cited 14× · PMID 23865727 · DOI 10.1185/03007995.2013.825591

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Seoul National University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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