Bioequivalence study on two terazosin hydrochloride tablets / 药学实践杂志
Journal of Pharmaceutical Practice
; (6): 419-422, 2015.
Article
em Zh
| WPRIM
| ID: wpr-790500
Biblioteca responsável:
WPRO
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 followst1/2(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 .
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1
Índice:
WPRIM
Tipo de estudo:
Clinical_trials
Idioma:
Zh
Revista:
Journal of Pharmaceutical Practice
Ano de publicação:
2015
Tipo de documento:
Article