Bioequivalence of Esomeprazole Capsules vs.Esomeprazole Tablets in Healthy Volunteers
- VernacularTitle:2种埃索美拉唑制剂的人体生物等效性研究
- Author:
Gang CHEN
- Publication Type:Journal Article
- Keywords:
Esomeprazole;
HPLC;
Bioequivalence
- From:
China Pharmacy
1991;0(02):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the pharmacokinetic characteristics of esomeprazole capsules versus esomeprazole tablets in healthy volunteers and to evaluate their bioequivalence.METHODS:A single oral dose of 40 mg esomeprazole capsules or esomeprazole tablets was given to 24 healthy male volunteers who were randomly assigned to two groups in an open randomized crossover test.The plasma concentration was determined by HPLC.The pharmacokinetic parameters of esomeprazole were analyzed by DAS 2.0 program.The bioequivalence of the two preparations was evaluated.RESULTS:The pharmacokinetic parameters of esomeprazole capsules and esomeprazole tablets were as follows:Cmax were(884.71?265.97)ng?mL-1 and(919.53?218.44)ng?mL-1;tmax were(1.45?0.39)h and(1.65?0.45)h;t1/2 were(2.30?0.51)h and(2.23?0.47)h;AUC0～12 were(3 897.50?1 033.58)ng?h?mL-1 and(4 059.57?1 715.07)ng?h?mL-1;AUC0～∞ were(4 222.70?1 066.73)ng?h?mL-1 and(4 320.22?1 426.73)ng?h?mL-1.The relative bioavailability of esomeprazole capsules was(96.01 ?10.5)%.CONCLUSION:Esomeprazole capsules and esomeprazole tablets are bioequivalent.
