2008•Journal of Henan Medical College for Staff and WorkersRequires access

Bioequivalence of Sparfloxacin Enteric Capsules Vervus Tablets

MA Xiang-qin

Abstract

Objective To evaluate the bioequivalence of Sparfloxacin tables.Methods Eighteen healthy volunteers were randomly administrated with an oral single and crossover dose of Sparfloxacin tablets 400 mg each.The serum concentration of Sparfloxacin was measured by HPLC.The pharmacokinetics parameters were calculated using 3P97 practical pharmacokinetics program. Results The pharmacokinetic parameters of Sparfloxacin,two kinds of tables were as the following: t1/2(15.09±2.31) vs.(14.34±1.93)h,Cmax(1.93±0.07)vs.(1.90±0.07) mg/L,Tmax(3.17±0.38) vs.(3.17±0.38)h,AUC0-12h(36.93±4.44)vs.(38.23±4.43)mg.h/L,AUC0-∞(39.48±4.58) vs.(40.61±4.46)mg.h/L.The relative bioavailability of Sparfloxacin,two kinds of tables were(96.6±4.2)%vs.(97.2±4.0)%.Conclusion Sparfloxacin,two kinds of tables are bioequivalent.

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Key concepts: Sparfloxacin, Bioequivalence, Pharmacokinetics, Bioavailability, Cmax, Pharmacology, Medicine, High-performance liquid chromatography