A comparative evaluation of bioequivalence of Gan & Lee glargine U300 and Toujeo in Chinese healthy male participants.

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), and the maximum glargine concentration within 24 hours post-dose (C). The primary PD endpoints were the area under the glucose infusion rate (GIR) curve from 0 to 24 hours (AUC) and the maximum GIR within 24 hours post-dose (GIR).

RESULTS

GL Glargine U300 demonstrated comparable PK parameters (AUC, C, AUC, and AUC of M1) and PD responses [AUC, GIR, AUC, and AUC] 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.