Bioequivalence of sustained-release tamoxifen citrate tablets in healthy volunteers
LIANG Yu-guang,GAO Hong-zhi,LIN Li-na,HU Jin-chao,LIU Ze-yuan(Department of Pharmacology, Affiliated Hospital, Academy of MilitaryMedical Sciences, Beijing 100071,China)
Objective To evaluate bioequivalence of tamoxifen citrate sustained-released tablets in healthy volunteers. MethodsA single oral dose of tamoxifen citrate tablet was given respectively to 20 healthy volunteers in a two-way cross over test for comparison of relative bioavailability in human.Tamoxifen citrate serum concentration was determined by HPLC-MS-MS.ResultsThe main pharmaeokinetic parameters of test and reference preparation were as follows: Cmax were (28.02±18.05),(44.43±13.53)μg·L-1;tmax were(7.35±2.30),(4.30±0.92)h;t1/2(ke) were(130.25±49.49),(120.87±34.22)h;AUC0-tn were(3.14±1.09),(3.42±1.16)mg·h·L-1;AUC0-∞ were(3.44±1.20),(3.69±1.31)mg·h·L-1,respectively,and F0-tn,F0-∞ of test preparation were (92.79±16.97)%,(94.79±15.78)%. Conclusion The test preparation was bioequivalent to the reference preparation,but Cmax was lower and tmax longer in test preparation .The results indicate that the sustained-release tablets clearly have the characteristic of slow releasing properties.
【CateGory Index】： R96