Bioequivalence and relative bioavailability of domestic and imported repaglinide tablets in healthy volunteers
- VernacularTitle:国产与进口降糖药瑞格列奈片的生物等效性研究
- Author:
Jinhong HU
;
Zhen LI
;
Xiaodong LIU
;
Lin XIE
;
Guorong FAN
;
Hongjie SONG
;
Jing SHI
- Publication Type:Journal Article
- From:
Academic Journal of Second Military Medical University
2001;22(5):432-434
- CountryChina
- Language:Chinese
-
Abstract:
Objective：To evaluate bioequivalence and relative bioavailability of domestic and imported repaglinide tablets in healthy volunteers. Methods： Twenty two healthy male volunteers were randomized into A and B groups. A single dose (4 mg) of domestic and imported repaglinide tablets were given respectively according to an open 2-way crossover study design. The washout period was 1 week. Plasma concentrations of repaglinide were determined by HPLC method. Results：The pharmacokinetic parameters of domestic and imported drugs were as follows: t1/2 were(0.86±0.24) and (0.83±0.31) h；tmax were( 0.79±0.37) and (0.75±0.41) h；cmax were (52.43±20.92) and (53.32±24.94) μg/L. AUC0-t were (79.87±36.48) and (74.95±30.57) μg*h*L-1，respectively. The relative bioavailability of domestic formulation was (106.55±16.15)%. Conclusion： The results of variance analysis and two one-side t test show that 2 formulations are of bioequivalence.
