QTMeds

Drug Database Monograph

KIGABEQ 100 mg

✓ VERIFIED BY DOCTOR

Active Ingredient: VIGABATRINE

QTc Interval Status:
neutre

Clinical Description (Database Summary)

In a Phase I thorough QT crossover study, healthy participants received a therapeutic dose (3.0 g) and a supratherapeutic dose (6.0 g). The results showed no signal of QTc prolongation for any correction method (QTcF​,QTcB​,QTcI​). All upper 95% confidence intervals remained below the 10 ms regulatory threshold. No relationship was found between plasma concentrations and QTcF.

Scientific Sources / References

https://doi.org/10.1016/j.clinthera.2017.06.006

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