Merck, Rahway, New Jersey, USA.
J Clin Pharmacol. 2011 Oct;51(10):1439-48. doi: 10.1177/0091270010382010. Epub 2010 Dec 8.
These studies were designed to demonstrate that the alendronate (ALN) component of an ALN/vitamin D(3) combination tablet was bioequivalent to the 70-mg ALN tablet and that the pharmacokinetic parameters of vitamin D(3) were similar with or without ALN. These were open-label, randomized, 2-part, 2-period, crossover studies. In part I, participants received either a single combination tablet or ALN 70 mg. In part II, participants received either a single combination tablet or vitamin D(3) alone. Results from part I showed that the geometric mean ratio (GMR) for total urinary excretion of ALN for both studies fell within the prespecified bioequivalence bounds. Results from part II showed that the pharmacokinetic profiles of vitamin D(3) with or without ALN were also similar. The combination tablets are bioequivalent to the ALN 70-mg tablet with respect to ALN bioavailability. The bioavailability of vitamin D(3) is similar in the combination tablets and when administered alone. No serious adverse experiences were reported.
这些研究旨在证明阿仑膦酸钠（ALN）与维生素 D（3）联合片剂中的 ALN 成分与 70mg ALN 片剂具有生物等效性，并且维生素 D（3）的药代动力学参数与是否存在 ALN 相似。这些都是开放标签、随机、两部分、两周期交叉研究。在第一部分，参与者接受了单一联合片剂或 ALN 70mg。在第二部分，参与者接受了单一联合片剂或单独的维生素 D（3）。第一部分的结果表明，两项研究中总的尿中 ALN 排泄的几何均数比值（GMR）都在规定的生物等效性范围内。第二部分的结果表明，无论是否存在 ALN，维生素 D（3）的药代动力学特征也相似。联合片剂在 ALN 生物利用度方面与 70mg ALN 片剂具有生物等效性。维生素 D（3）的生物利用度在联合片剂和单独使用时相似。没有报告严重的不良反应经验。
