Active Ingredient: SUGAMMADEX
Sugammadex is a modified gamma-cyclodextrin for reversal of rocuronium- and vecuronium-induced neuromuscular blockade that demonstrates no clinically significant prolongation of cardiac repolarization or QTc intervals. In an ICH E14 thorough QTc six-period crossover study in 84 healthy volunteers with moxifloxacin positive control, therapeutic (4 mg/kg) and supratherapeutic (32 mg/kg) doses, administered alone or with rocuronium (1.2 mg/kg) or vecuronium (0.1 mg/kg), produced placebo-adjusted mean QTcI changes ranging from 2.1 to 4.3 ms. Upper 95% confidence bounds remained strictly below 10 ms at all postdose timepoints.
https://doi.org/10.1007/s40261-013-0095-8, https://doi.org/10.5414/cp201693, https://doi.org/10.2165/11537210-000000000-00000