The Effect of Food Intake on Pharmacokinetics of Lansoprazole OD Tablet

Background and Objective Insufficient absorption of proton pump inhibitor(PPI)might be a treatment refractory factor, however, limited evidences were reported on the effect of pharmacokinetic parameter of PPI when taking the drug after food intake. The aim of this study was to compare the pharmacokinetic parameter of lansoprazole orally dispersing(LPZ-OD)tablet between conditions of taking the drug after food intake and under fasting conditions.
Methods Nine healthy male volunteers took LPZ-OD(Takepron®OD)tablet 30 mg either 15 minutes after breakfast or under fasting conditions in a cross-over fashion. The wash-out period of each term was 7 days at least. Blood samples were taken for measurement of pharmacokinetic parameter of LPZ.
Results The AU0-inf, Cmax, and tmax in the drug administration after food intake were significantly decreased than that of fasting conditions. The respective AUC0-inf was 4512±1958 ng・h/mL and 3083±1688 ng・h/mL(p<0.05), Cmax was 1275±528 ng/mL and 624±307 ng/mL(p<0.05), and tmax was 2.0±0.8 h and 3.3±1.0 h(p<0.05). No significant difference in t1/2 was observed.
Conclusions This study suggested food intake may affect pharmacokinetic parameters(AUC0-inf, Cmax, and tmax)of LPZ-OD tablet.