Why the study?
Does supratherapeutic repeated dosing of strontium ranelate prolong the QTc interval in healthy subjects?
Population
96 healthy male and female subjects, mean age 27.7 ± 7.5 years
Comparison
Strontium ranelate 4 g/day oral for 15 days vs Placebo and positive control
Design
RCT, randomized, crossover design, double-blind, double dummy
Follow-up
16 days
Authors
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Supratherapeutic strontium ranelate does not cause clinically significant QTc prolongation; confirms cardiac safety per ICH E14 guidelines.
Does supratherapeutic repeated dosing of strontium ranelate prolong the QTc interval in healthy subjects?
Supratherapeutic repeated oral doses of strontium ranelate do not cause clinically significant QTc prolongation, confirming its cardiac safety profile in accordance with ICH E14 guidelines.
Täubel et al. (2012) studied this question.
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