Jornal de Bioequivalência e Biodisponibilidade

Abstrato

Comparation of Bioavailability: Two Dexlansoprazole Formulations in Beagle Dogs after a Single Dose Administration

Jiaqi Zhang, Jinlong Qi, Yaru Wu, Zhongning Zhu, Suwen SU, Xueyan Chen, Yanfang Xu and Qingzhong Jia

The study was performed to determine oral bioequivalence of generic dexlansoprazole and reference formulation (Dexilant) in healthy dogs. A 2 period crossover balanced design was used with a 7 days washout period between the doses. Dexlansoprazole was analyzed by LC-MS/MS in the presence of omeprazole as internal standard. The mean ratio of parameters Cmax and AUC0-t and 90% confidence intervals of correspondents were calculated to determine the bioequivalence. The means AUC0-t for test and reference formulation were 4094.5 ug/L*h and 3684.9 ug/L*h, for AUC0-∞ were 4137.5 ug/L*h and 3709.6 ug/L*h and, for Cmax 1643.0 ug/L and 1498.2 ug/L, respectively. Geometric mean of the test /reference Pharmaceuticals 30 mg formulation individual percent ratio was 99.3% for AUC0-t, 100.6% for AUC0-∞ and 110.0% for Cmax. The 90% confidence intervals were 84.0% ~ 117.5%, 85.3% ~ 118.7%, 85.0% ~ 142.3%, respectively. It was concluded that pharmacokinetic data for test formulation were similar enough to original innovator, both formulations had the delayed releasing and double peak characteristics in dogs according to the rate and extent of absorption.