Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin-R with the US-licensed Humulin® R formulation in healthy subjects: Results from the RHINE-1 (Recombinant Human INsulin Equivalence-1) study.

ABSTRACT:

Aim

To establish equivalence in the pharmacokinetic (PK) and pharmacodynamic (PD) endpoints between proposed biosimilar Insulin-R (Biocon's Insulin-R) and Humulin® R using the euglycaemic clamp technique in healthy subjects.

Materials and methods

In this phase-1 automated euglycaemic glucose clamp study, 42 healthy subjects were randomized (1:1) to receive a single dose of 0.3 IU/kg of Biocon's Insulin-R and Humulin-R. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 12 hours. Primary PK endpoints were area under the insulin concentration-time curve from 0 to 12 hours (AUC_ins.0-12h ) and maximum insulin concentration (C_ins.max ). Primary PD endpoints were area under the GIR time curve from 0 to 12 hours (AUC_GIR.0-1

SUBMITTER: Plum-Morschel L 

PROVIDER: S-EPMC9303355 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature