Active Ingredient: AMISULPRIDE
Amisulpride, was found to inhibit in vitro hERG current with an IC50 of around 100 μM However, in a randomized, double-blind, placebo-controlled, 3-period crossover study of 30 healthy volunteers, a therapeutic dose of 10 mg IV (administered twice, 2 hours apart) led to a maximum mean placebo-corrected change-from-baseline QTcF (ΔΔQTcF) of 5.2 ms (90% CI: 3.53–6.96 ms) after the first dose, and 8.0 ms (90% CI: 5.49–10.58 ms) after the second dose. When 10 mg IV amisulpride was simultaneously coadministered with ondansetron (4 mg IV), the maximum mean ΔΔQTcF was 7.3 ms (90% CI: 5.48–9.16 ms). Concentration-QTcF modeling showed a minimal slope (0.006 ms/ng/mL). Caution is advised
https://www.fda.gov/media/178811/download, https://doi.org/10.3389/fphar.2020.565704, https://doi.org/10.1111/bcp.13128, https://doi.org/10.1007/s40264-013-0032-z, https://doi.org/10.1213/ane.0000000000004538, https://doi.org/10.1097/jcp.0b013e3181e5c14c