Active Ingredient: EXENATIDE
(Hérité de BYETTA 10 microgrammes) In a thorough QT crossover study of 62 healthy subjects, a subcutaneous dose of 10μg showed no clinically significant QT prolongation compared to placebo. The upper bound of the 90% confidence interval for the placebo-corrected QTc change (ΔΔQTc) remained below the 10 ms regulatory threshold for both Fridericia (QTcF) and individual (QTcI) corrections. While a minor correlation was noted between plasma exenatide and ΔΔQTcF, it is likely confounded by the drug's glucose-lowering effect.
Analyse RCP (Automatique), id : 69937274