Evaluation of bioequivalence of domestic glimepiride tablet in Chinese healthy male volunteers
- VernacularTitle:国产格列美脲片剂在健康男性志愿者的生物等效性评价
- Author:
Shaohua WANG
;
Anjin CHEN
;
Baodong YU
;
Xiao CHU
;
Jie SHI
;
Meiling ZHAO
;
- Publication Type:Journal Article
- Keywords:
glimepiride;
HPLC;
bioequivalence
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2002;0(05):-
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To compare the bioequivalence of glimepiride tables and capsules with a single dose. METHODS: Twenty Chinese healthy male volunteers were enrolled in a randomized crossover study with a single oral dose 3 mg of two formulations respectively. The blood drug concentration in serum was measured by HPLC, and the pharmacokinetic parameters were calculated by 3p97 software and compared by two one side t test. RESULTS: The parameters of the tables and the capsules were( 1.23 ? 0.19 ) and ( 1.31 ? 0.22 ) mg?h?L -1 at AUC (0-t) ,( 1.32 ? 0.20 ) and ( 1.45 ? 0.24 ) mg?h?L -1 at AUC (0-inf) ,( 0.30 ? 0.05 ) and ( 0.30 ? 0.06 ) mg?L -1 at C max ,( 6.6 ? 2.5 ) and ( 9.3 ? 7.9 ) h the peak time (T peak ), respectively. There were no significant differences between the two formulations. F was 96.4 ? 21.1 calculated by AUC (0-t) and 96.4 ? 21.1 by AUC (0-inf) . CONCLUSION: Glimepiride tables and capsules are of bioequivalence.
