Effect of High‐Fat Meal on the Pharmacokinetics and Safety of Lansoprazole Enteric‐Coated Capsules in Healthy Chinese Subjects

The effects of food on the pharmacokinetics (PKs) and safety of 30‐mg lansoprazole enteric‐coated capsules in healthy Chinese subjects were investigated from a bioequivalence trial. A randomized, open‐label, four‐period crossover study was conducted in 73 healthy subjects under both fasted and fed conditions. Serial blood samples were collected, and plasma lansoprazole concentrations were determined by liquid chromatography‐tandem mass spectrometry. PK parameters were calculated using a non‐compartmental model with Phoenix WinNonlin Version 8.3 software. The bioequivalence module of WinNonLin was used to statistically analyze the maximum plasma concentration (C max ), the area under the concentration–time curve from zero to the last measurable concentration (AUC 0‐t ), and the area under the concentration–time curve from zero to infinity (AUC 0‐∞ ) of lansoprazole in plasma. The results demonstrated bioequivalence between the test (T) and reference (R) formulations for all evaluated PK parameters. Compared with the fasted state, the C max , AUC 0‐t , and AUC 0‐∞ of lansoprazole significantly decreased by 60.67%, 46.39%, and 44.25%, respectively, following oral administration of lansoprazole 30 mg in the fed state. The incidence of adverse events (AEs) was similar between the fasted and fed states, with no serious AEs observed. Overall, food markedly reduced systemic exposure of 30 mg oral lansoprazole in Chinese subjects, indicating that food intake significantly affects its bioavailability.