A bioavailability/bioequivalence study of two oral lansoprazole formulations after single administration to healthy volunteers

Two oral lansoprazole formulations, containing encapsulated microgranules, Lasoprol((R)) (test formulation) and Lartzor((R)) (reference), were adminis tered to 12 healthy volunteers of both sexes in a single dose of 30 mg lans oprazole in order to investigate their comparative bioavailability. No stat istically significant differences, at the probability level of 90%, were ob served neither for the maximal serum concentrations (1.12: 1.22 mug/ml) nor for the area under the concentration-time curves (5.01 : 5.77 mug/ml (.) h ), the parameter to which the inhibition of acid secretion induced by lanso prazole is directly related. The similar holds true for the value of time t o reach the maximal concentration of lansoprazole in scrum, although this p arameter was previously described as less sensitive in comparative bioavail ability studies. The terminal elimination half-lives were 4.56 h for Lasopr ol((R)) and 4.57 h for the reference formulation. The results indicate the bioequivalence and good tolerability of both lansoprazole formulations. The overall pharmacokinetic profile of the drug was comparable with the data p reviously reported by other investigators.