Abstract：
This was an open-label, randomized, single-dose, 2-period, crossover clinical trial with an adaptive design to evaluate the bioequivalence and comparative pharmacokinetics of generic glecaprevir/pibrentasvir versus the brand name product in healthy White male and female volunteers under fed conditions. Safety profiles were also assessed. A total of 56 healthy adult volunteers were enrolled and randomly assigned in a 1:1 ratio to receive a single dose of either the generic or reference formulation. After a 7-day washout period, subjects received the alternate product. Blood samples were collected at pre-specified time points up to 48 hours post-dosing. Plasma concentrations of glecaprevir and pibrentasvir were determined using a validated high-performance liquid chromatography-tandem mass spectrometry method. The geometric mean ratios of the test to the reference formulation for maximum plasma concentration (Cmax) and area under the concentration-time curve from drug administration to the last measurable concentration (AUC0-t) fell within the predefined bioequivalence range of 80%-125%. Both formulations demonstrated comparable pharmacokinetic profiles for glecaprevir and pibrentasvir, and can be considered bioequivalent. No adverse events were reported, and both formulations were well tolerated by all participants.
摘要：
这是一个开放的标签，随机化，单剂量,2期，具有适应性设计的交叉临床试验，以评估通用glecaprevir/pibrentasvir与品牌产品在健康的白人男性和女性志愿者中的生物等效性和比较药代动力学条件。还评估了安全性。共招募56名健康成人志愿者，并以1：1的比例随机分配以接受单一剂量的通用或参考制剂。经过7天的清洗期,受试者接受替代产品。在预先指定的时间点收集血样直至给药后48小时。使用经过验证的高效液相色谱-串联质谱法测定glecaprevir和pibrentasvir的血浆浓度。从药物施用到最后可测量浓度(AUC0-t)的最大血浆浓度(Cmax)和浓度-时间曲线下面积的测试与参考制剂的几何平均比率落在80%-125%的预定生物等效性范围内。两种制剂对glecaprevir和pibrentasvir的药代动力学特征具有可比性，可以认为是生物等效的。未报告不良事件，所有参与者对这两种制剂的耐受性都很好。
