Pharmacokinetics and Bioequivalence of Metformin Hydrochloride Enteric-coated Tablets
- VernacularTitle:盐酸二甲双胍肠溶片的药动学及生物等效性研究
- Author:
Jie GAO
- Publication Type:Journal Article
- Keywords:
Metformin hydrochloride enteric-coated tablet;
HPLC;
Pharmacokinetics;
Bioequivalence
- From:
China Pharmacy
2005;0(20):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the pharmacokinetics and relative bioavailability of metformin hydrochloride enteric-coated tablets and validate the bioequivalence between the domestic and the imported metformin hydrochloride enteric-coated tablets.METHODS:An oral single dose(1 000 mg)of domestic or imported metformin hydrochloride enteric-coated tablets was given to 26 healthy volunteers in a randomized crossover study.The time-concentrations of metformin hydrochloride were determined by HPLC.The pharmacokinetic parameters as well as relative bioavailability of the domestic tablets were computed.RESULTS:The concentration-time curves of the two kinds of metformin hydrochloride enteric-coated tablets were in line with one-compartment model.The main pharmacokinetic parameters of the domestic vs.the imported metformin hydrochloride enteric-coated tablets were as follows:Cmax(84.9?16.4)?g?L-1 vs.(84.5?13.8)?g?L-1;tmax(0.67?0.07)h vs.(0.77?0.08)h;t1/2 Ke(1.90?0.17)h vs.(1.79?0.19)h;AUC0～t(161.9?16.8)?g?h?L-1 vs.(157.2?19.7)?g?h?L-1;AUC0～∞(179.7?18.2)?g?h?L-1 vs.(173.4?19.2)?g?h?L-1.The relative bioavailability of the domestic enteric-coated tablets was(109.0?7.2)% as against the imported enteric-coated tablets.CONCLUSION:The two kinds of tablets were bioequivalent.
