Bioequivalence Studies of Rivaroxaban at Two Different Strengths: Rivaroxaban 10 mg under Fasting Conditions and Rivaroxaban 20 mg under Fed Conditions in Healthy Mexican Subjects

González-de la Parra M
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Abstract

The goal of these two studies was to evaluate the bioequivalence of two strengths of rivaroxaban 10 mg and 20 mg. Because the food effect on the pharmacokinetics of rivaroxaban affects the strength of 20 mg and not that of 10 mg. The 20 mg strength study was conducted under fed conditions, whereas the 10 mg strength study was conducted under fasting conditions. The two studies were conducted separately with different sets of Mexican subjects of both genders using a randomized, singledose, 2-sequence, 2-period cross over design with a 7-day washout period. Blood samples from the subjects were obtained at basal conditions, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00 and 48.00 hours after administration. Rivaroxaban plasma concentrations were quantified using an HPLC method coupled to a mass spectrometer. The test and reference formulations were considered to be bioequivalent if the 90% CI for the ratios (test/reference) of geometric means were within the acceptance limits of 80 to 125% for the pharmacokinetic parameters Cmax, AUC0–t and AUC0–∞. In both studies the 90% CI for all pharmacokinetic parameters were within the limits of acceptance. Therefore the conclusion of bioequivalence was reached.
两种不同强度利伐沙班的生物等效性研究:墨西哥健康受试者在空腹条件下服用 10 毫克利伐沙班和在进食条件下服用 20 毫克利伐沙班的生物等效性研究
这两项研究的目的是评估 10 毫克和 20 毫克两种强度的利伐沙班的生物等效性。因为食物对利伐沙班药代动力学的影响只影响 20 毫克的强度,而不影响 10 毫克的强度。20 毫克强度研究是在进食条件下进行的,而 10 毫克强度研究是在空腹条件下进行的。这两项研究分别在不同组别的墨西哥男女受试者中进行,采用随机、单剂量、2序列、2周期交叉设计,并有7天的冲洗期。受试者的血样分别在基础状态、用药后 0.25、0.50、0.75、1.00、1.25、1.50、1.75、2.00、2.50、3.00、3.50、4.00、6.00、8.00、10.00、12.00、24.00、36.00 和 48.00 小时采集。利伐沙班的血浆浓度采用与质谱仪联用的高效液相色谱法进行定量。如果药代动力学参数 Cmax、AUC0-t 和 AUC0-∞ 的几何平均比(试验/参照)的 90% CI 在 80% 至 125% 的接受范围内,则认为试验制剂和参照制剂具有生物等效性。在这两项研究中,所有药代动力学参数的 90% CI 均在接受范围内。因此得出了生物等效性的结论。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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