Abstract
BACKGROUND: To assess the bioequivalence between Gan & Lee (GL) glargine U300 and Toujeo(®) regarding pharmacokinetics (PK), pharmacodynamics (PD), and safety in Chinese healthy male participants. METHODS: A single-center, randomized, double-blind, single-dose, two-preparation, two-sequence, four-cycle repeated crossover design study was performed to compare GL glargine U300 and Toujeo(®) in 40 healthy participants. The primary PK endpoints were the area under the curve of glargine metabolites, M1 concentration from 0 to 24 hours (AUC(0-24h)), and the maximum glargine concentration within 24 hours post-dose (C(max)). The primary PD endpoints were the area under the glucose infusion rate (GIR) curve from 0 to 24 hours (AUC(GIR.0-24h)) and the maximum GIR within 24 hours post-dose (GIR(max)). RESULTS: GL Glargine U300 demonstrated comparable PK parameters (AUC(0-24h), C(max), AUC(0-12h), and AUC(12-24h) of M1) and PD responses [AUC(GIR.0-24h), GIR(max), AUC(GIR.0-12h), and AUC(GIR.12-24h)] to those of Toujeo(®), as indicated by 90% confidence intervals ranging from 80% to 125%. No significant disparities in safety profiles were observed between the two treatment groups, and there were no reported instances of serious adverse events. CONCLUSION: The PK, PD, and safety of GL glargine U300 were bioequivalent to that of Toujeo(®). CLINICAL TRIAL REGISTRATION: https://www.chinadrugtrials.org.cn/, identifier CTR20212419.