Study on Bioequivalence of Domestic Oxcarbazepine Dispersible Tablets
- VernacularTitle:国产奥卡西平分散片的人体生物等效性研究
- Author:
Rong DU
;
Juan CHEN
- Publication Type:Journal Article
- Keywords:
Oxcarbazepine;
MHD;
Pharmacokinetics;
Bioavailability;
Bioequivalence
- From:
China Pharmacy
2005;0(18):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To study the bioequivalence of domestic oxcarbazepine dispersible tablets. METHODS: 20 healthy male volunteers were randomly given oxcarbazepine dispersible tablets (test tablet) and oxcarbazepine tablets (reference tablet) via p.o. The plasma concentration of active metabolite (MHD) of oxcarbazepine were determined by HPLC. 3p97 software was used to calculate pharmacokinetic parameters and the bioequivalence of oxcarbazepine were evaluated. RESULTS: After treatment main pharmacokinetic parameters of test tablet vs. reference tablet were as follows: Cmax(4.231?0.841) ?g?mL-1 vs. (4.350?0.861) ?g?mL-1; tmax(4.13?0.43) h vs. (4.28?0.44) h; t1/2(14.17?2.66) h vs. (14.44?2.09) h; AUC0～60 (113.00?22.25) mg?h?L-1 vs. (118.11?14.20) mg?h?L-1; AUC0～∞(126.35?20.94) mg?h?L-1 vs. (130.54?16.17) mg?h?L-1. The relative bioavailability of test tablet to reference tablet was (95.67?12.80)%. CONCLUSION: Two kinds of tablets were bioequivalent.
