Evaluation of the relative bioavailability between two formulations of olmesartan medoxomil 40mg, in orodispersible tablet form and coated tablet form, in healthy participants of both sexes

Abstract

The objective of this study was to verify whether the test formulation of olmesartan medoxomil, in orodispersible tablet form, administered with water (treatment B) and without water (treatment C), presents a rate and extent of absorption equivalent to the reference formulation, film-coated tablet form (treatment A). Study design was monocentric, open-label, crossover and randomized. Olmesartan medoxomil 40 mg was orally administered, under fasting conditions to healthy participants. Blood collections were carried out over a period of 72 hours. Olmesartan plasma concentrations were determined by liquid chromatography coupled to mass spectrometry detector techniques. Pharmacokinetic parameters Cmax, AUC0-t, AUC0-inf, Tmax, T1/2, Kel, %AUC_extrap were determined. Confidence intervals were constructed for the ratio of the geometric means between the test and comparator treatments (B/A and C/A) for Cmax and AUC(0-t), using ln-transformed data. Formulations were well tolerated, with no serious adverse events observed. The 90% CI for the B/A ratio was 89.50%-102.63% for the Cmax parameter and 89.72%-100.89% for the AUC(0-t) parameter, while for the C/A ratio it was 83.22%-95.40% for the Cmax parameter and 85.18%-95.77% for the AUC(0-t) parameter. In conclusion, the test formulation of olmesartan medoxomil, in orodispersible tablet form, administered with and without water, is bioequivalent to the reference formulation.