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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
Phase 1 trial testing Experimental DW224aa in Healthy in 32 participants. Completed.
1 May 2011
Quick facts
| Lead sponsor | Seoul National University Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Enrollment | 32 |
| Start date | 1 April 2011 |
| Primary completion | 1 May 2011 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Experimental DW224aa — full drug profile →
- Experimental DW224a — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
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.
-
Cmax of zabofloxacin in plasma
Time frame: Up to 48 -
AUClast of zabofloxacin in plasma
Time frame: Up to 48
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):
-
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 -
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 -
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:
- PubMed search for NCT01341249
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01341249 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Seoul National University Hospital
- Last refreshed: 15 July 2011
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01341249.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing