Pharmacokinetics and bioequivalence of omeprazole capsules

Objective To develop a HPLC method for determinating the content of omeprazole capsules in human plasma and study the pharmacolinetics and bioavailability of them.Methods A randomized two-way cross-over study design was adopted.18 volunteers were randomly divided into two omeprazole formulations respectively,the results were analyzed by program DAS 2.0.Results The concentration-time curves of two omeprazole capsules were conformed to the one-compartment open model.The main pharmacokinetic parameters were as follows:T1/2 were(1.76±0.79) h and(1.66±0.52) h,Tmax were(2.73±0.35) h and(2.61±0.4) h,Cmax were(1 271.09±351.72) ng/mL and(1 219.02±325.53) ng/mL,AUC0→∞ were(2 941.85±807.18) ng/(h·mL) and(2 960.57±802.91)ng/(h·mL) respectively.The relative bioequivalence was(99.63±12.04)%.Conclusion The fomulations were bioequivalent.