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首页> 外文期刊>International journal of clinical pharmacology and therapeutics >Oxcarbazepine final market image tablet formulation bioequivalence study after single administration and at steady state in healthy subjects.
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Oxcarbazepine final market image tablet formulation bioequivalence study after single administration and at steady state in healthy subjects.

机译：在健康受试者中单次给药并处于稳态后，奥卡西平最终市场影像片剂的生物等效性研究。

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A final market image (FMI) tablet formulation of oxcarbazepine was compared with the marketed formulation (current market formulation (CMF)) and with the clinical trial formulation (CTF) tablet used during clinical efficacy and safety studies. The goal of the study was to compare the bioavailability after single doses and at steady state of the FMI versus CMF and CTF as well. Additionally, the effect of food was evaluated on the final market formulation. The study was an open-label, single-center, 4-way crossover trial. Each treatment period consisted of a single dose of 600 mg OXC on Day 1. From Day 4 up to including Day 7, 600 mg b.i.d. were administered. A final dose of 600 mg was administered in the morning on Day 8. Blood samples were taken on Day 1 before and on Day 7 (predose) and on Day 8 (morning dose). Plasma concentrations of MHD (the main metabolite of OXC) were determined by using a validated HPLC assay. FMI as test formulation was compared with the CMF and CTF as reference formulations. FMI under fed conditions was also compared with FMI under fasting conditions. These comparisons were made using data following single-dose administration and steady state conditions. Plasma AUC for single dose or AUC(0-12h) for steady state, and plasma Cmax, log-transformed (natural base), were used for the assessment of bioequivalence. The 90% confidence interval (CI) approach was used for testing bioequivalence. Bioequivalence was accepted if the CI was contained within the region (0.8, 1.25). At steady state under fed conditions, tested formulation (FMI) was bioequivalent to CTF and with the reference marketed formulation (CMF) with regard to AUC and Cmax. After single dose under fed conditions, FMI and CTF were bioequivalent with regard to AUC and Cmax, and FMI and CMF were equivalent with regard to AUC but not Cmax. Food had no effect on the bioavailability of the FMI. These results clearly support the switch from the current market formulation (CMF) to the final market image tablet in the countries where Trileptal is or was already registered.
机译：将奥卡西平的最终市场形象（FMI）片剂与上市制剂（当前市场制剂（CMF））以及在临床疗效和安全性研究期间使用的临床试验制剂（CTF）片剂进行了比较。该研究的目的是比较FMI与CMF和CTF的单次给药后以及稳态下的生物利用度。此外，评估了食品对最终市场配方的影响。这项研究是一项开放标签，单中心，四路交叉试验。每个治疗期在第1天包括600 mg OXC的单剂量。从第4天到第7天（含第7天），每天600 mg。被管理。在第8天早晨施用600mg的最终剂量。在第1天之前和第7天（给药前）和第8天（早晨剂量）采集血样。 MHD（OXC的主要代谢产物）的血浆浓度通过使用经过验证的HPLC分析确定。将FMI作为测试制剂与CMF和CTF作为参考制剂进行了比较。还比较了进食条件下的FMI与禁食条件下的FMI。这些比较是使用单剂量给药和稳态条件后的数据进行的。单剂量血浆AUC或稳态时的AUC（0-12h）和对数转化（天然碱）的血浆Cmax用于评估生物等效性。 90％置信区间（CI）方法用于测试生物等效性。如果CI包含在区域内（0.8，1.25），则表示具有生物等效性。在进料条件下处于稳定状态时，就AUC和Cmax而言，被测制剂（FMI）与CTF等效，与参考市售制剂（CMF）等效。在进食条件下单剂给药后，FMI和CTF在AUC和Cmax方面是生物等效的，而FMI和CMF在AUC方面是等效的，但Cmax不是。食物对FMI的生物利用度没有影响。这些结果清楚地支持了Trileptal已注册或已经注册的国家从当前市场配方（CMF）转向最终市场图像平板电脑。

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