阿仑膦酸钠/胆钙化醇(维生素D3)片70 mg/5600 IU两种剂型的药代动力学:开放标签、随机、单剂量、两治疗、两期、两顺序、交叉、生物等效性研究

S. Tippabhotla, S. Thota, Sohel Md. Khan, C. Gadiko, Sandeep Yergude, Raju Cheerla, Mukesh Nakkawar, Madhava Rao Betha, R. Battula, V. Vobalaboina
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引用次数: 2

摘要

摘要:阿仑膦酸钠与胆骨化醇(维生素D3) 70mg /5600 IU片联合应用固定剂量治疗骨质疏松症。本研究旨在评估阿仑膦酸钠/胆骨化醇(维生素D3)片70 mg/5600 IU试验配方与对照配方在110名健康成年男性志愿者空腹条件下的生物等效性。这是一项开放标签、随机、单剂量、双向交叉研究,洗脱期为14天。所有可能的努力都是为了稳定内源性胆骨化醇的基线水平。胆骨化醇和阿仑膦酸钠分别在给药前96 h至给药后96 h和0 ~ 24 h采集血样。阿仑膦酸钠和胆骨化醇采用不同的LC-MS/MS方法进行定量。采用基线调整方法- 1(每次给药后浓度减去平均浓度)和方法- 2(给药后AUC减去个体AUC)推导胆钙化醇的AUC0-t参数,并根据方法- 1获得的数据得出生物等效性。阿仑膦酸钠和基线调整后的胆骨化醇的Cmax和AUC0-t的90% CI在80.00-125.00%的监管接受范围内,被认为是生物等效的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Pharmacokinetics of two formulations of alendronate sodium/cholecalciferol (vitamin D3) tablets 70 mg/5600 IU: An open-label, randomized, single-dose, two-treatment, two-period, two-sequence, cross-over, bioequivalence study
Abstract A fixed dose combination of alendronate and cholecalciferol (vitamin D3) 70 mg/5600 IU tablets has been indicated for the treatment of osteoporosis. This study was aimed to assess bioequivalence between test and reference formulations of alendronate sodium/cholecalciferol (vitamin D3) tablets 70 mg/5600 IU in 110 healthy adult male volunteers under fasting conditions. This was an open label, randomized, single dose, two way cross-over study, separated by a washout period of 14 days. All possible efforts were made to stabilize the baseline endogenous levels of cholecalciferol. Blood samples were collected from 96 h pre-dose to 96 h post-dose and 0–24 h for cholecalciferol and alendronate, respectively. Quantification of alendronate and cholecalciferol was done using distinct validated LC-MS/MS methods. Two baseline adjusted methods, method-I (subtraction of the average concentration from each post-dose concentration) and method-II (subtraction of the individual AUC from post-dose AUC) were applied for deriving the AUC0–t parameter of cholecalciferol, among which bioequivalence was concluded based on data obtained using method-I. The 90% CI of Cmax and AUC0–t for alendronate and baseline adjusted cholecalciferol were within the regulatory acceptance limit of 80.00–125.00% and considered as bioequivalent.
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