Study on bioequivalence of Lansoprazole Enteric-coated Capsules in healthy volunteers

Objective: To study the relative bioequivalence of Lansoprazole Enteric-coated Capsules in human body. Methods: The plasma concentrations of Lansoprazole Enteric-coated Capsules in 18 healthy male volunteers were deter- mined by HPLC method in randomized crossover way after being orally administered with single dose of 30 mg of the test preparation and the reference preparation produced by two different pharmaceutical factory in China. The pharmacokinetic parameters and the relative bioequivalence of the test preparation and the reference preparation were calculated by DAS2.0 software. Results: The main pharmacokinetic parameters of the test preparation and the reference preparation were as follows: tmax were (2.5±0.7) and (2.7±0.7) h, Cmax were (895.4±352.8) and (866.5±301.2) μg/ml, t1/2 were (2.0±0.5) and (2.1±0.9) h, AUC0-t were (3 515.5±2 120.8) and (3 521.0±1 986.1) μg/(h·L),AUC0-∞were (3 684.9±2 306.9) and (3 753.9±2 229.3) μg/(h·L) respectively. The relativebioavailability of Lansoprazole Enteric-coated Capsuleswas(98.2±10.6)%.Conclusion:The test preparation and the reference preparation are bioequivalent.