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A randomized, open-label study assessing the bioequivalence of two formulations of Fingolimod 0.5 mg in healthy subjects
AAPS Open Pub Date : 2018-03-09 , DOI: 10.1186/s41120-018-0023-3
Mario Tanguay , Thomas Fröhlich , Mathieu Drouin , Gerald Beuerle

Fingolimod is an oral agent approved for the treatment of relapsing forms of multiple sclerosis (MS), which has demonstrated efficacy in Phase III trials in patients with relapsing-remitting MS (RRMS). The present study was designed to assess bioequivalence between a fingolimod Test capsule formulation (Teva Argentina, formerly IVAX Argentina S.A.) and a Reference capsule formulation (Novartis Pharma GmbH, Germany). In a single-center, randomized, single-dose, open-label, two-way crossover study under fed conditions, 16 healthy volunteers were randomized to receive a single oral dose of 0.5 mg of the Test and Reference formulations, with a 42-day washout period between administrations. The three pharmacokinetic (PK) parameters employed in the study to assess the bioequivalence between the Test and Reference formulations were maximum plasma concentration (Cmax), time to Cmax (Tmax), and area under the concentration–time curve from time zero to 72 h (AUC0–72). No significant differences between the Test and Reference formulations for any of the three PK parameters were observed. Based on 90% geometric confidence intervals (CIs) within 80% to 125% for both AUC0–72 and Cmax, the Test and Reference formulations were considered bioequivalent.

中文翻译:

一项随机,开放标签的研究,评估0.5 mg芬戈莫德两种制剂在健康受试者中的生物等效性

芬戈莫德(Fingolimod)是一种经批准用于治疗复发形式的多发性硬化症(MS)的口服药物,已在III期临床试验中证明对复发缓解型MS(RRMS)患者有效。本研究旨在评估芬戈莫德测试胶囊制剂(Teva Argentina,前身为IVAX Argentina SA)与参考胶囊制剂(Novartis Pharma GmbH,德国)之间的生物等效性。在喂食条件下的单中心,随机,单剂量,开放标签,双向交叉研究中,将16名健康志愿者随机接受0.5 mg测试和参考制剂的单次口服剂量,其中42-两次给药之间的每日清除期。该研究中用于评估测试和参考制剂之间生物等效性的三个药代动力学(PK)参数是最大血浆浓度(Cmax),达到Cmax的时间(Tmax)以及从时间零到72 h的浓度-时间曲线下的面积(AUC0–72)。对于三个PK参数中的任何一个,在测试配方和参考配方之间均未观察到显着差异。根据AUC0-72和Cmax的90%几何置信区间(CI)在80%至125%之间,测试和参考制剂被认为具有生物等效性。
更新日期:2018-03-09
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