Bioequivalence evaluation of two rabeprazole enteric coated formulations in healthy Chinese volunteers.
A bioequivalence study of two rabeprazole enteric-coated formulations was carried out in 20 healthy Chinese volunteers according to a single dose, two-sequence, crossover randomized design. The two formulations were administered in two treatment days, separated by a washout period of 7 days. Blood samples were collected at specified time intervals over 10 hours post-dosing. Plasma samples were separated and assayed for rabeprazole using a selective and sensitive HPLC method with UV detection. The pharmacokinetic parameters AUC(0-T), AUCmax, Cmax, tmax, t(1/2) and MRT were determined from plasma concentration-time profile of both formulations. ANOVA and two one-sided t test procedures showed no significant difference in log-transformed Cmax, AUC(0-T) AUC(0-infinity) while the 90% confidence interval (CI) of the ratio of the geometric means of their values were also used to assess bioequivalence between the two formulations. The results of this study indicated that the two rabeprazole formulations can be considered to be bioequivalent.
Chen
Jun
J
Department of Pharmaceutics, School of Pharmacy, Fudan University, Shanghai, PR China.
Jiang
Wen Ming
WM
Gao
Xiao Ling
XL
Jiang
Xinguo
X
Zhang
Qi Zhi
QZ
Zheng
Zhao Hua
ZH
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D001562:Benzimidazoles / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001682:Biological Availability; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D009853:Omeprazole / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics*; D064750:Rabeprazole; D013056:Spectrophotometry, Ultraviolet; D013608:Tablets, Enteric-Coated; D013810:Therapeutic Equivalency
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D001562:Benzimidazoles; D002214:Capsules; D004791:Enzyme Inhibitors; D013608:Tablets, Enteric-Coated; D064750:Rabeprazole; D009853:Omeprazole