Publication: Clinical Pharmacology in Drug Development
Abstract
This publication examines the effect of food on the pharmacokinetics and safety of 30-mg lansoprazole enteric-coated capsules, evaluated as part of a bioequivalence trial in healthy Chinese subjects. In a randomized, open-label, four-period crossover study of 73 subjects, plasma lansoprazole concentrations were measured by LC-MS/MS, and pharmacokinetic parameters were calculated by non-compartmental analysis using Phoenix WinNonlin, including its bioequivalence module. The test and reference formulations were bioequivalent across all measured parameters, but a high-fat meal significantly reduced systemic exposure, with Cmax, AUC0-t, and AUC0-inf decreasing by 61%, 46%, and 44%, respectively, compared with the fasted state. Adverse event rates were similar between fasted and fed conditions. The results indicate that food intake substantially affects lansoprazole bioavailability in this population.
Author(s): Wang Y, Huang X, Han D, Duan L, Wang Q, Zhang Z, Liu M, Du L, Wang J
Published: 2026 年 6 月 1 日
Phoenix WinNonlin: Food-Effect Analysis Made Practical
When a high-fat meal changes drug exposure, Phoenix WinNonlin is what turns that crossover data, like the lansoprazole results here, into a clear bioequivalence conclusion. As part of a Phoenix platform relied on by more than 11,000 users worldwide, Phoenix WinNonlin remains the gold standard engine for noncompartmental analysis, PK/PD, and toxicokinetic modeling.
