Bioequivalence study on two terazosin hydrochloride tablets
10.3969/j.issn.1006-0111.2015.05.009
- VernacularTitle:两种盐酸特拉唑嗪片的人体生物等效性研究
- Author:
Leilei ZHU
1
;
Lixia GUO
;
Yan ZHAN
;
Furong QIU
;
Tongfang ZHAO
;
Yujie YE
;
Weian YUAN
;
Anping LI
;
Minghua LI
;
Shufang SU
;
Jian JIANG
Author Information
1. 上海中医药大学附属曙光医院临床药理科
- Keywords:
terazosin hydrochloride;
LC-MS/MS;
bioequivalence
- From:
Journal of Pharmaceutical Practice
2015;(5):419-422
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the bioequivalence of domestic and imported terazosin hydrochloride tablets after single oral dose .Methods It was a single center ,randomized ,open ,cross-over trail design ,21 subjects were fasting oral adminis-tered of 2 mg domestic and imported terazosin hydrochloride tablets in different periods ,venous blood 4 ml were collected in different time points before and 60 h after administration ,plasma concentration of terazosin was determined by LC-MS/MS . Results The main pharmacokinetic parameters of domestic and imported terazosin hydrochloride tablets were as follows :t1/2 :(13.2± 2.39)hvs(12.5±1.93)h,tmax :(1.01±0.83)hvs(1.08±0.69)h,Cmax :(40.1±10.6)ng/mlvs(37.3± 9 .57) ng/ml;AUC0- ∞ :(428 ± 82 .1) ng · h/ml vs (426 ± 85 .2) ng · h/ml .The relative bioavailability of domestic terazosin hydrochloride tablets was (101 .2 ± 14 .7)% .90% CI of domestic and imported terazosin hydrochloride tablets AUC0-t and Cmax geometric mean ratio fell between 80% -125% .Conclusion The domestic tablets are bioequivalent to the imported tablets .
