2007•Pharmaceutical Journal of Chinese People's Liberation ArmyRequires access
Determination of Finasteride in Human Plasma by LC-MS and Study on its Bioequivalent
Ning Wei
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Abstract
Aim To study the pharmacokinetics and relative bioavailability of finasteride tablets in Chinese healthy volunteers.Methods:Twenty male healthy volunteers received 2mg finasteride tablet orally in a random crossover design.Drug concentrations in plasma were determined by LC-MS.Results:The main pharmacokinetic parameters of tested and reference tablets were as follows:AUC0-24(123.95±25.47)μg·h·L-1 vs (126.35±28.16)μg·h·L-1,AUC0-∞(126.12±27.48)μg·h·L-1 vs (129.85±29.12)μg·h·L-1,Cmax(22.17±3.83)μg·L-1 vs (22.48±4.69)μg·L-1,Tmax(3.1±0.6)h vs (2.9±0.8)h,T1/2(4.2±0.3)h vs(4.3±0.5)h.respectively.The relative bioavailability of the test tablet was(99.4±9.2 )%;Conclusions:The results demonstrated that the two tablets were bioequivalent.