Active Ingredient: GABAPENTINE
Gabapentin enacarbil is a prodrug of gabapentin that demonstrates no clinically significant effect on cardiac repolarization or QTc intervals. In a randomized ICH E14 thorough QT crossover study in healthy adults, therapeutic (1200 mg) and supratherapeutic (6000 mg) doses showed maximum placebo-corrected QTcF differences of 3.55 ms and 1.20 ms, with upper 95% confidence bounds of 5.66 ms and 3.32 ms, respectively, remaining strictly below the 10 ms regulatory threshold. Concentration-QTc relationship was flat, confirming an absence of exposure-dependent repolarization delay
https://doi.org/10.1016/j.clinthera.2012.01.002, https://doi.org/10.1016/S0887-8994(03)00405-3, https://www.fda.gov/media/178811/download, https://doi.org/10.1016/j.clinthera.2013.10.011