Active Ingredient: EMPAGLIFLOZINE
In a randomized, double-blind, placebo-controlled, 5-period crossover Thorough QT (TQT) study of 30 healthy volunteers, single therapeutic (25 mg) and supratherapeutic (200 mg) oral doses were evaluated. Moxifloxacin (400 mg) was used as an open-label positive control. The primary endpoint, mean change from baseline in the population heart rate-corrected QT interval (ΔΔQTcN) between 1–4 hours post-dose, was 0.6 ms (90% CI: −0.7,1.9) for the 25 mg dose and −0.2 ms (−1.4,0.9) for the 200 mg dose. Both values are well below the regulatory ICH E14 concern threshold of 10 ms. Assay sensitivity was fully confirmed by moxifloxacin (12.4 ms). Empagliflozin demonstrated an excellent cardiac safety profile and was well tolerated.
https://doi.org/10.1186/1475-2840-12-70