生物学的同等性とバイオアベイラビリティのジャーナル

概要

Bioequivalence Study of Metoclopramide Hydrochloride 10 mg Tablets in Healthy Male Volunteers

Rosalba Alonso-Campero, Roberto Bernardo-Escudero, María Teresa de Jesús Francisco-Doce, Myriam Cortés-Fuentes, Gilberto Castañeda-Hernandez and Mario I. Ortiz

The aim of this study was to determine if two oral solid formulations of 10 mg of metoclopramide hydrochloride are bioequivalent, after the administration of one dose PO, in fasting conditions, in healthy male subjects. This study used a single dose, randomized, single-blind, controlled, 2 x 2 cross-over, under fasting conditions, design to compare the 2 products. Subjects received one oral dose of the metoclopramide 10 mg tablet on each treatment period, which were separated by a seven-day wash-out period. Plasma concentrations of unaltered metoclopramide were analyzed by High Performance Liquid Chromatography. Pharmacokinetic parameters were obtained. Schüirmann’s unilateral double t test was performed. Null hypotheses indicating bioinequivalence (p > 0.05) were rejected. Bioequivalence was determined if the quotient of the parameters of C max , AUC 0-t and AUC 0-∞ were between 80 % and 125%, at a power of 80% (α >0.08). Twenty-five volunteers were enrolled in the study, all were Mexicans with the mean ± SD age of 27 ± 8 years, height 171 ± 7 cm, weight 70.4 ± 7.3 kg and body mass index: 24.11 ± 2.33 kg/m 2 . The mean AUC 0-∞ C max , t max and t½ were 237.02 ng/h/mL, 36.74 ng/mL, 0.95 h and 5.0 h, respectively, for the test drug and 238.90 ng/h/ml, 37.28 ng/mL, 0.95 h and 4.81 h for the reference product. This bioavailability comparison in this selected group of healthy male volunteers failed to detect statistically significant differences between the products. These results met the regulatory criteria for assuming bioavailability.