Bioequivalence of ciprofloxacin tablets in healthy volunteers
- VernacularTitle:环丙沙星片剂人体生物等效性研究
- Author:
Xin TANG
;
Ying HUANG
;
Quan WEN
;
Zeyuan LIU
- Publication Type:Journal Article
- Keywords:
ciprofloxacin;
HPLC;
pharmacokinetics;
bioequivalence
- From:
Chinese Pharmacological Bulletin
2003;0(09):-
- CountryChina
- Language:Chinese
-
Abstract:
Aim To study the relative bioequivalence of two domestic ciprofloxacin tablets. Methods Therandomized and crossover study was conducted in 18 healthy volunteers.After a single dose of the drugs,their plasma drug concentration was determined using HPLC.Results Both the two domestic ciprofloxacin tablets fit to one compartment model. The main pharmacokinetics parameters of the tested and reference ciprofloxacin were as followings: C_(max):(2.503?0.394) and (2.706?0.579) mg?L~(-1);T_(max):(1.343?0.402) and (1.075?0.379) h;T_(12):(4.174?1.201) and (3.826?1.005) h; AUC_(0-tn): (10.528?2.204) and (10.643?1.922) mg?L~(-1)?h;AUC_(0-∞): (11.409?2.139) and (11.558?2.160) mg?L~(-1)?h;F_(0-tn) and F_(0-∞) was (100.245?18.447)% and (100.470?20.108)%,respectirely. Conclusion The tested and reference formulations are bioeqivalent.
