Abstract: [
Abstract ] Objective Toevaluatethebioequivalenceof2kindsofentecavirpreparationsin
humanbodies.Methods Therandomized , crossed-overstudy wasconductedin20 healthy
volunteers.AfterAsingleoraldoseofentecavirhydrochloridetestandreferencepreparations
(
containing0. 5mgentecavir ), thedruglevelsinplasmaweredeterminedbyhighperformance
liquid chromatography-tandem mass spectrometry.The pharmacokinetic parameters were
calculatedwithDAS3. 2. 7software , thenbioequivalenceofthetwopreparationswasevaluated.
Results ThepeakconcentrationsC max , t max , t 1 / 2 and AUC 0-72h ofthe2formulations were
(
4. 41±1. 02 ) μ g / Land ( 4. 36±0. 89 ) μ g / L ,( 0. 66±0. 19 ) hand ( 0. 70±0. 29 ) h ,( 46. 11±32. 32 )
hand ( 61. 28±93. 69 ) h ,( 13. 31±2. 63 ) μ g · h
-1 · L -1 and (
13. 10±2. 20 )
mg
· h
-1 · L -1 ,
respectively.Conclusion Theresultsshowthatthetwoformulationsarebioequivalent.The
relativebioavailabilityofentecaviris ( 103. 3±14. 0 ) %.

Key words: entecavir , bioavailability , HPIC-MS / MS