Bioequivalence and food effect study of two zaltoprofen preparations in healthy Chinese volunteers


International Journal of Clinical Pharmacology and Therapeutics
Ying SongAidong Wen

Abstract

Zaltoprofen, a propionic acid derivative of nonsteroidal anti-inflammatory drug (NSAID), has powerful anti-inflammatory and analgesic effects on inflammatory pain. This study was undertaken to investigate the effect of food on the pharmacokinetic parameters of zaltoprofen capsule (trial preparation, T) and tablet (reference preparation, R), and to assess the relative bioequivalence of two zaltoprofen preparations. In this open-label, randomized, crossover, two-state, four-period study, 24 healthy Chinese volunteers were randomized to receive a single oral dose of zaltoprofen capsule/tablet (80 mg) under fasting and fed state. Plasma samples were obtained for 24 hours and measured by a developed LC-MS/MS method. Pharmacokinetic parameters were calculated using noncompartmental analysis. Safety and tolerability were assessed throughout the study. 24 healthy participants received two zaltoprofen preparations. For zaltoprofen capsule and tablet, coadministration of high-fat food significantly decreased C<sub>max</sub> by 23 and 22%, respectively; t<sub>max</sub> was prolonged by 0.7 hours and 0.8 hours, while the AUC<sub>last</sub> (for T, geometric mean ratio (GMR): 101.81%, 90% confidence interval (CI): 94.71 - 108.14%; for R, GM...Continue Reading

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