Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic‐Euglycemic Clamp Procedure
Ekaterina Koksharova,
Roman Drai,
Sergei Noskov
et al.
Abstract: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 infusi… Show more
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