Active Ingredient: CLOBAZAM
(Hérité de URBANYL 10 mg) Clobazam (a benzodiazepine antiepileptic drug) and its active metabolite, N-desmethylclobazam (N-CLB), do not prolong the cardiac corrected QT interval (QTc). In a Phase I, randomized, double-blind Thorough QT (TQT) study of 280 healthy participants, maximum therapeutic (40 mg/day) and supratherapeutic (160 mg/day) dosages were evaluated alongside moxifloxacin. Mean changes from baseline in placebo-corrected QTc using Fridericia, Bazett, and individual corrections (QTcF, QTcB, QTcI) revealed zero effect on repolarization. Linear mixed-effects modeling showed that the concentration-effect slopes for both clobazam and N-CLB were near zero or slightly negative. Variations in the CYP2C19 genotype (poor metabolizers) affect N-CLB plasma profiles but carry no proarrhythmic potential. The drug demonstrates an excellent cardiac safety profile.
https://www.fda.gov/media/178811/download, https://doi.org/10.1016/j.clinthera.2017.08.020