Study on Bioequivalence of Finasteride Tablets in Human Body
- VernacularTitle:非那雄胺片的人体生物等效性研究
- Author:
Chen GAO
;
Zhigang ZHAO
;
Dongmei LI
;
Li ZHU
;
Wei SHAO
;
Jingtian WANG
- Publication Type:Journal Article
- Keywords:
Finasteride;
HPLC;
Bioequivalence
- From:
China Pharmacy
2001;0(10):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the human body bioequivalence of finasteride tablets from both domestic and im?port.METHODS:The serum concentration of18volunteers were determined by HPLC after a random cross single oral dose of10mg of finasteride tablets,the pharmacokinetic parameters and the relative bioavailability were calculated and the bioequiva?lence was evaluated as well.RESULTS:For the domestic and the import finasteride tablets,the AUC (0～t) of which were(990.80?302.80)(?g?h)/L and(1007.46?333.65)(?g?h)/L respectively,the C max of which were(119.22?18.48)?g/L and(114.08?22.97)?g/L respectively,the t max of which were(2.89?1.02)h and(2.64?0.54)h respectively,the relative bioavailability of the domestic preparation was(103.35%?29.75)%of the imported one.CONCLUSION:The domestic and import finasteride tablets were of bioequivalence.
