Pharmacokinetic and pharmacodynamic similarity between SAR341402 insulin aspart and Japan-approved NovoRapid in healthy Japanese subjects.

ABSTRACT: This study compared the pharmacokinetic and glucodynamic profiles of biosimilar SAR341402 insulin aspart to Japan-approved insulin aspart (NovoRapid) in healthy Japanese males. In this single-center, randomized, double-blind, single-dose, two-period, crossover study, subjects received 0.3 U/kg of SAR341402 or NovoRapid before undergoing a 10 h euglycemic clamp procedure. Plasma insulin aspart concentrations and blood glucose levels were measured, and glucose infusion rates (GIRs) were assessed. Primary endpoints were maximum plasma insulin aspart concentration (INS-C_max), area under the plasma insulin concentration-time curve to the last quantifiable concentration (INS-AUC_last), area under the GIR-time curve during the clamp (GIR-AUC_0-10 h), and maximum GIR

SUBMITTER: Shiramoto M 

PROVIDER: S-EPMC8617249 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature