Active Ingredient: AGOMELATINE
Agomelatine is a melatonergic agonist and 5-HT2c antagonist antidepressant that demonstrates no clinically significant effect on cardiac repolarization or QTc intervals. In a randomized, double-blind, crossover thorough QT/QTc study in 60 healthy volunteers with moxifloxacin positive control, single therapeutic (50 mg) and supratherapeutic (400 mg) doses demonstrated that the upper bounds of the one-sided 95% confidence intervals for placebo-adjusted QTcP differences remained strictly below the 10 ms regulatory concern threshold at all 10 postdose timepoints. No concentration-QTc relationship was identified.
https://doi.org/10.1097/fjc.0000000000000136