Study on the Bioequiavailability of Two Sertralines Hydrochloride Formulations in Healthy Volunteers
- VernacularTitle:2种盐酸舍曲林制剂人体生物等效性研究
- Author:
Aidong WEN
;
Min ZHOU
;
Zhifu YANG
;
Yin WU
;
Zhirui WANG
;
Zhijun FENG
- Publication Type:Journal Article
- Keywords:
Sertraline;
Bioequiavailability;
LC/MS/MS
- From:
China Pharmacy
1991;0(05):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the bioequiavailability of two sertraline hydrochloride formulations in healthy volunteers.METHODS:A randomized, crossover study of 22 healthy volunteers receiving single oral dose of 50mg sertraline hydrochloride solution(test preparation) or sertraline hydrochloride tablets(comparator preparation) was conducted and the blood concentrations determined by LC/MS/MS.RESULTS: The pharmacokinetic parameters for the test sertraline and the comparator sertraline were as follows:t1/2 were (27.3?5.2)h and (26.3?3.0)h,respectively;Cmax were(9.56?2.49)?g?L-1 and(9.43?2.91)?g?L-1,respectively;tmax were(5.18?1.47)h and(6.00?1.07)h,respectively;AUC0～108 were(329?112)?g?h?L-1 and (297?111)?g?h?L-1,respectively;AUC0～∞ were(354?127)?g?h?L-1 and (316?122)?g?h?L-1,respectively.There were no significant differences in main pharmacokinetics parameters between the 2 preparations,except in tmax from analysis of variance and one-side & two-sides t tests.The relative bioavailability of the test sertraline was(115.5?26.7)%.CONCLUSION:These two sertraline hydrochloride formulations are bioequivalent.
