Estudio de bioequivalencia entre dos productos: Trimebutina de liberación prolongada de Laboratorios LETI S. A. V., vs Debridat AP® de Laboratorios PFIZER, luego de administrar una dosis única de 300 mg en voluntarios sanos

Objective: The objective of this study is to assess the bioequivalence of two sustained release formulations of trimebutine 300 mg, after a single administration in healthy volunteers, through determination of the active metabolite desmethyl-trimebutine. Methods: This is an open, randomized, balanced, active-controlled, single dose, crossover study with two periods separated by a rest period and sequentially, conducted in 12 healthy volunteers of both sexes. Volunteers were assigned according to the randomization scheme and two periods, a single oral dose after fasting for 10 hours, a tablet formulation containing 300 mg of trimebutine AP LETI SAV Laboratories, or product Reference DEBRIDAT AP®, Pfizer Laboratories. After the last blood sample of the first period there will be a wash time of seven days, after which the volunteers received the test product in the first period will received the reference product and viceversa. The sampling is performed: before dosing (time zero), 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 24 h and 36 h. Statistical analysis was performed using a statistical package Equiv test program, using analysis of variance (ANOVA) of the kinetic parameters AUC0-inf, AUC0-36h and Cmax and application of confidence intervals for 90%. In the comparative analysis we used the confidence intervals with the reference range of 0.8-1.25%. Results: For the Trimebutine test values were Cmax 1343.49 +/- 585.58, AUC0-36 of 8197.19 +/- 3995.23 and AUC0-inf 8198.36 +/- 3995.3. For the formulation of reference values were: Cmax 1023.99 +/- 587.57, AUC0-36 7221.15 +/- 3211.97 y AUC0-inf of 7225.97 +/- 3211.62 no significant differences between groups. Conclusions: This study found that the Cmax and AUC, its log-transformed means and confidence intervals 90% away from each other not less than 80% or over 125%, so that both products are considered bioequivalent and therefore interchangeable. [PUBLICATION ABSTRACT]