Study on the relative bioavailability and bioequivalence of lansoprazole tablets

Purpose To study the relative bioavailability and bioequivalence of lansoprazole tablets and lansoprazole enteric capsules in human plasma.Methods 24 healthy volunteers in randomized crossover study were given a single oral dose of 30 mg of the test or of the reference.12 h later,blood was taken out at several time points.The plasma level of lansoprazole was determined by HPLC.The pharmacokinetic parameters were calculated and the bioavailability and bioequivalence of two formulations were evaluated by DAS2.1 program.Results Cmax of the test formulation and the reference one were(949.8±329.0) and(973.2±322.2) ng/mL,tmax were(2.44±0.52) and(2.06±0.70) h,t1/2 were(1.97±1.12) and(1.84±1.11)h,AUC0→12 were(3 054±2 019) and(2 911±1 818) ng·h/mL,AUC0→∞ were(3 398±2 825) and(3 106±2 138) ng·h/mL,respectively.The 90% confidential interval of Cmax,AUC0→12 and AUC0→∞ of the test were 90.7%-104.0%,94.0%-110.8% and 94.9%-112.2%,respectively.The relative bioavailability was(105.0±24.6)% for the test and reference preparation.Conclusion These two formulations are bioequivalent.