Abstract

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 (C max ) and area under the concentration‐time curve from drug administration to the last measurable concentration (AUC 0‐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.