哈尔滨三联药业氟比洛芬凝胶贴膏启动生物等效性试验 适应症为骨关节炎等疾病

Group 1 - The core point of the article is that Harbin Sanlian Pharmaceutical Co., Ltd. has initiated a bioequivalence trial for its Fluorobufen gel patch (40mg) in healthy subjects in China, with the trial registered under CTR20254749 and first published on November 27, 2025 [1][2] - The trial aims to compare the absorption speed and extent of the test formulation against a reference formulation under fasting conditions, assessing the bioequivalence of the two formulations [1][2] - The primary endpoints of the trial include Cmax, AUC0-t, and AUC0-∞ measured over 72 hours post-administration, while secondary endpoints include Tmax, t1/2z, λz, Ct, and AUC_%Extrap, along with monitoring adverse events and other health metrics [2] Group 2 - The current status of the trial is ongoing, and recruitment has not yet started [3]