Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic-Euglycemic Clamp Procedure.

Autor: Koksharova E; Endocrinology Research Center, Moscow, Russia., Drai R; R&D Center, GEROPHARM, Saint-Petersburg, Russia., Noskov S; City Hospital No. 3, Yaroslavl, Russia., Dorotenko A; R&D Center, GEROPHARM, Saint-Petersburg, Russia., Protsenko E; R&D Center, GEROPHARM, Saint-Petersburg, Russia., Radaeva K; R&D Center, GEROPHARM, Saint-Petersburg, Russia., Arefeva A; R&D Center, GEROPHARM, Saint-Petersburg, Russia., Gefen M; R&D Center, GEROPHARM, Saint-Petersburg, Russia., Galstyan G; Endocrinology Research Center, Moscow, Russia., Makarenko I; R&D Center, GEROPHARM, Saint-Petersburg, Russia.
Jazyk: angličtina
Zdroj: Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2024 Jul; Vol. 13 (7), pp. 828-836. Date of Electronic Publication: 2024 Mar 21.
DOI: 10.1002/cpdd.1401
Abstrakt: The aim of the study was to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of T-glu (GP40321, test drug), and reference insulin glulisine in a hyperinsulinemic-euglycemic clamp procedure. During this study, 34 healthy male volunteers underwent the hyperinsulinemic-euglycemic clamp procedure following subcutaneous 0.3 U/kg injection of T-glu or reference insulin glulisine in a randomized, double-blind, crossover study. Plasma glucose levels were monitored every 5 minutes for 8 hours. Glucose infusion rate adjustment was based on the blood glucose measurements. Evaluation of PD was performed using the glucose infusion rate values, while PK was calculated using insulin concentrations measured via enzyme-linked immunosorbent assay. The study results showed that the 90% CI for the geometric mean ratios of primary PK and PD of T-glu and reference insulin glulisine were within 80%-125% comparability limits, and that the safety profiles were comparable. PK, PD, and safety similarity of T-glu and reference insulin glulisine was demonstrated.
(© 2024, The American College of Clinical Pharmacology.)
Databáze: MEDLINE
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