Bioequivalence of domestic and imported ceftibuten tablets in healthy volunteers
10.3969/j.issn.1001-6821.2010.01.006
- VernacularTitle:国产与进口头孢布烯片在健康人体的生物等效性
- Author:
Min-Ji WEI
1
;
Pu ZHANG
;
Li ZHANG
;
Yuan LV
;
Cai-Yun ZHAO
;
Yan LIU
;
Man ZHANG
;
Tian-Yun LI
Author Information
1. 北京大学第一医院
- Keywords:
ceftibuten;
HPLC;
pharmacokinetic;
bioequivalence
- From:
The Chinese Journal of Clinical Pharmacology
2010;26(1):19-22
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the bioequivalence of domestic and im-ported cefiibuten tablets in healthy volunteers.Methods A single oral doses of 400 mg ceflibuten was given to 22 healthy volunteers in an open randomized crossover design.The concentrations of ceftibuten in plasma were determined by a HPLC method.The pharmacokinetic parameters of domestic and imported were calculated by 3 P97 software.Results The main phannacokinetic parameters of domestic and imported were as follow:t_(max) were(2.18±0.97)and(2.43±0.81)h;C_(max) were(18.58±2.70)and(18.95±4.38)μg·mL~(-1);t_(1/2) were(2.41±0.86)and (2.36±0.70)h;AUC_(0-t) were(95.76±14.54)and(96.14±18.87)μg·h·mL~(-1),respectively.The relative bioavailability of ceftibuten was(101.77±17.72)%.Conclusion The results demonstrated that the two preparations of cefiibuten were bioequivalent.
