Studies on bioequivalence of levofloxacin hydrochloride capsule in healthy volunteers
- VernacularTitle:盐酸左氧氟沙星胶囊的人体生物等效性研究
- Author:
Yan QIAN
- Publication Type:Journal Article
- Keywords:
Levofloxacin capsul;
Bioequivalence;
Bioavailability;
HPLC
- From:
Journal of Chongqing Medical University
1987;0(01):-
- CountryChina
- Language:Chinese
-
Abstract:
0bjective:To study the bioequivalence of two Levofloxacin capsules in healthy volunteers.Methods:A single oral dose of 200mg test or reference preparations was given to 18 healthy male volunteers in a randomized crossover study.The serum concentration of Levofloxacin was determined by HPLC with the fluorescence detector.The pharmacokinetic parameters and the relative bioavailability were calculated by DAS to evaluate the bioequivalence.Results:The main pharmacokinetic parameters of test and reference preparations were as follow:Cmax(3.206?0.498)?g/ml and(3.255?0.436)?g/ml;tmax(0.931?0.307)h and(0.903?0.322)h;AUC0~36(23.780?4.986)(?g.h)/ml and(23.934?5.625)(?g.h)/ml;AUC0~∞(24.510?5.189)(?g.h)/ml and(24.684?5.973)(?g.h)/ml,respectively.The relative bioavailability of the test capsule to the reference one was(103.9?29.1)%.Conclusion:The results of statistic analysis showed that the test and reference Levofloxacin hydrochloride capsules were bioequivalent.
