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DOI: 10.1055/s-0031-1296674
Evaluation of the Bioequivalence and Pharmacokinetics of Two Formulations of Secnidazole after Single Oral Administration in Healthy Volunteers
Publication History
Publication Date:
21 December 2011 (online)
Abstract
The pharmacokinetic parameters of two oral formulations of a 1 g dose of secnida-zole (CAS 3366-95-8, secnidazole tablet as reference and another capsule preparation as test) were compared in an open-label, randomized, single oral dose, two-period cross-over design in 18 healthy volunteers under fasting conditions. Plasma concentrations of secnidazole were measured by a validated HPLC chromato-graphic assay. The parametric 90 % confidence intervals of the geometric mean values of the test/reference ratios were 91.9 % to 105.9 % (point estimate: 99.39 %) for AUC0–∞, 92.7 % to 104.4 % (point estimate: 98.61 %) for AUC0–t, 97.6 % to 107.1 % (point estimate: 102.31 %) for Cmax, being within the acceptance criteria for bioequivalence (80 %-125 %). Tmax values were analyzed by the nonparametric Wilcoxon test and the difference was not statistically significant. Therefore, it is concluded that the test and reference secnidazole formulations are bioequivalent for both the extent and the rate of absorption.