A bioavailability/bioequivalence study of two oral lansoprazole formulations after single administration to healthy volunteers.
Two oral lansoprazole formulations, containing encapsulated microgranules, Lasoprol (test formulation) and Lanzor (reference), were administered to 12 healthy volunteers of both sexes in a single dose of 30 mg lansoprazole in order to investigate their comparative bioavailability. No statistically significant differences, at the probability level of 90%, were observed neither for the maximal serum concentrations (1.12:1.22 micrograms/ml) nor for the area under the concentration-time curves (5.01:5.77 micrograms/ml.h), the parameter to which the inhibition of acid secretion induced by lansoprazole is directly related. The similar holds true for the value of time to reach the maximal concentration of lansoprazole in serum, although this parameter was previously described as less sensitive in comparative bioavailability studies. The terminal elimination half-lives were 4.56 h for Lasoprol 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 previously reported by other investigators.
Jovanović
D
D
Institute of Toxicology and Pharmacology, National Poison Control Centre, Military Medical Academy, Belgrade, FR Yugoslavia. ncktvma@eunet.yu
Kilibarda
V
V
Maksimović
M
M
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D005260:Female; D006207:Half-Life; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics*; D054328:Proton Pump Inhibitors; D013810:Therapeutic Equivalency
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D004791:Enzyme Inhibitors; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D009853:Omeprazole