Although no signal was observed in pre-clinical or clinical studies, the safety of strontium ranelate in accordance with the ICH E14 guidelines needed to be assessed in order to characterize the effect on QTc of repeated oral doses of strontium ranelate (4 g day1).WHAT THIS STUDY ADDS This...
A QTc prolongation over of 450 ms and new treatment-related repolarization change was noted in 1 (4%) patient. Conclusion: The study demonstrates that a combination therapy of 3 antiviral drugs does not significantly prolong the QTc interval and does not cause severe pathological changes on the ...
This study investigated the influence of QT and RR interval data quality and the precision of heart rate correction on the sample sizes of thorough QT/QTc studies. In 57 healthy subjects (26 women, age range 19–42 years), a total of 4,195 drug-free digital electrocardiograms (ECG) were ...