Evaluation of the bioequivalence and pharmacokinetics of two formulations of secnidazole after single oral administration in healthy volunteers.
The pharmacokinetic parameters of two oral formulations of a 1 g dose of secnidazole (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 chromatographic 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 AUC(0-infinity), 92.7% to 104.4% (point estimate: 98.61%) for AUC(0-t), 97.6% to 107.1% (point estimate: 102.31%) for C(max), being within the acceptance criteria for bioequivalence (80%-125%). T(max) 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.
Zhu
De Qiu
DQ
Department of Clinical Pharmacy, Tongji Hospital affiliated Tongji University, Shanghai, The People's Republic of China.
Hu
Kai Li
KL
Tao
Wei Xing
WX
Feng
Liang
L
Duan
Hu
H
Jiang
Xin Guo
XG
Chen
Jun
J
D000328:Adult; D000981:Antiprotozoal Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002214:Capsules; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D013607:Tablets; D013810:Therapeutic Equivalency
D000981:Antiprotozoal Agents; D002214:Capsules; D013607:Tablets; D008795:Metronidazole; C016724:secnidazole