Abstract：
Desvenlafaxine succinate is a selective serotonin-norepinephrine reuptake inhibitor for the treatment of major depressive disorder. The pharmacokinetic profile of desvenlafaxine succinate at the clinically recommended dose of 50 mg in Chinese healthy subjects has been reported rarely. The objective of this study was to evaluate the pharmacokinetics and bioequivalence of desvenlafaxine succinate in Chinese healthy subjects. A single-dose, open-label, randomized, two-way crossover study with a 7-day washout period was conducted. A total of 88 individuals were incorporated to show bioequivalence of a generic and a reference drug, with 48 individuals in the fasting state and 40 receiving a high-fat diet. Finally, 46 and 38 individuals completed the fasting and the fed study, respectively. The 90% confidence intervals of the adjusted geometric mean ratios for maximum plasma concentration, area under the concentration-time curve from time zero to the last measurable concentration, and area under the concentration-time curve from time zero to infinity all fell in the bioequivalent interval of 80%-125% in both the fasting and fed states. A total of 33 adverse events were reported, and all were mild or moderate in severity. In summary, the generic and reference formulations were bioequivalent, with no observable safety differences in the fasting/fed state.
摘要：
琥珀酸去文拉法辛是一种用于治疗重度抑郁症的选择性5-羟色胺-去甲肾上腺素再摄取抑制剂。临床推荐剂量为50mg的琥珀酸去文拉法辛在中国健康受试者中的药代动力学特征很少报道。本研究的目的是评估琥珀酸去文拉法辛在中国健康受试者中的药代动力学和生物等效性。单剂量,开放标签，随机化，我们进行了双向交叉研究,洗脱期为7天.共纳入88名个体，以显示仿制药和参考药的生物等效性，48人处于禁食状态，40人接受高脂肪饮食。最后,46和38个人完成了禁食和进食研究，分别。调整后的最大血浆浓度几何平均比率的90%置信区间，从时间零点到最后可测量浓度的浓度-时间曲线下的面积，在禁食和进食状态下，从零到无穷大的浓度-时间曲线下的面积均下降了80％-125％的生物等效间隔。共报告了33起不良事件，所有患者的严重程度均为轻度或中度。总之,通用和参考配方是生物等效的，在禁食/进食状态下没有可观察到的安全性差异。
