Active Ingredient: RALTEGRAVIR
In a thorough QT crossover study, a single supratherapeutic dose of 1600 mg was evaluated (achieving a Cmax approximately 4-fold higher than the standard clinical dose). The upper limit of the 90% confidence interval for the placebo-adjusted mean change in QTcF (ΔΔQTcF) remained consistently below 10 ms at all time points. No subjects experienced QTcF values >450 ms or increases from baseline >30 ms.
https://www.fda.gov/media/178811/download, https://doi.org/10.1177/0091270008318007