Bioequivalence of omeprazole enteric capsule

Objective: To evaluate the pharmacokinetics and bioequivalence of omeprazole enteric capsule in heslthy Chinese.Methods: Randomized cross-over design was adopted,18 healthy subjects took omeprazole enteric capsule and reference preparation 40 mg orally in one time.Serial blood samples were collected at scheduled intervals during 12 h.The samples were analyzed for omeprazole and reference preparation concentration in plasma by HPLC.The main pharmacokinetics parameters of the omeprazole and reference preparation were Calculated and analyzed.Results: The main pharmacokinetic parameters in test and reference preparation were following accordingly: Tmax were 2.39±0.40 and 2.33±0.42 h;Cmax were 0.632±0.383 and 0.626±0.415 mg/L;T1/2 were 1.92±0.64 and 2.01±0.73 h;Vd/F were 81.21±46.68 and 94.07±89.46 L;CL/F were 32.99±20.92 and 31.68±20.41 L/h;AUC0→12 were 2.03±1.99 and 1.89±1.62 mg/(h·L)-1.The relative bioavailability of omeprazole was 104.7±17.7%.Conclusion: The two omeprazole preparations are bioequivalent.