Study Results from R&D Center Provide New Insights into Antidiabetic Agents [Clinical Pharmacology of Gp40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability In a Hyperinsulinemic-euglycemic Clamp Procedure].

Předmět:
Zdroj: Drug Week; 4/16/2024, p2955-2955, 1p
Abstrakt: A study conducted in St. Petersburg, Russia compared the pharmacokinetics and pharmacodynamics of T-glu (GP40321) and reference insulin glulisine in a hyperinsulinemic-euglycemic clamp procedure. The study involved 34 healthy male volunteers and found that the primary pharmacokinetic and pharmacodynamic parameters of T-glu and reference insulin glulisine were within the comparability limits of 80%-125%. The safety profiles of the two drugs were also found to be comparable. The research concluded that T-glu is similar to reference insulin glulisine in terms of pharmacokinetics, pharmacodynamics, and safety. The study was supported by GEROPHARM, Russia. [Extracted from the article]
Databáze: Complementary Index