Publication: Drugs in R&D
Abstract
This open-label, crossover Phase I trial evaluated the bioequivalence and safety of a generic 500-mg metformin hydrochloride sustained-release tablet against the originator formulation (Glucophage XR) in 36 healthy Chinese adults under postprandial conditions. Plasma metformin was measured by LC-MS/MS and pharmacokinetic parameters analyzed using Phoenix WinNonlin. The 90% confidence intervals for AUC and Cmax adjusted geometric mean ratios fell within the standard bioequivalence range, and no serious adverse events occurred. The generic sustained-release metformin formulation was confirmed to be bioequivalent and well tolerated compared with the originator product under postprandial conditions.
Author(s): Sun ML, Liu HJ, Luo XD, Wang Y, Zhang W, Liu C, Wang X
Published: 2022 年 1 月 21 日
Phoenix WinNonlin: Generic-to-Originator Confidence
Phoenix WinNonlin's pharmacokinetic analysis confirmed bioequivalence between a generic and originator metformin sustained-release tablet in this postprandial study. Paired with AI PK Reports, Phoenix WinNonlin can help turn an analysis into a complete PK document in minutes rather than days, within a Phoenix platform used across more than 170 academic institutions.
