A Study to Compare the Pharmacokinetic Profiles of DW224aa and DW224a

Phase 1 Completed 32 enrolled Seoul National University Hospital Dong Wha Pharmaceutical Co. Ltd. · collab

RandomizedCrossoverOpen-label

Summary

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

Timeline

Start: 2011-04
Primary completion: 2011-05
Completion: —

Outcome

Met primary endpoint

paper The geometric mean ratios (90% confidence intervals) of the Cmax. AUClast, and AUCinf were 1.08 (1.00-1.17), 1.05 (1.00-1.10), and 1.05 (1.00-1.10), respectively, and were within the bioequivalence acceptance range of 0.8-1.25. PMID 23865727 ↗

paper Both DW224a and DW224aa exhibited comparable PK profiles and were bioequivalent in terms of PK parameters. PMID 23865727 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zabofloxacin	Small molecule	366.5 mg	Oral
Subject	Zabofloxacin	Small molecule	366.7 mg	Oral

Indications

No indication recorded.