Repeated supratherapeutic dosing of strontium ranelate over 15 days does not prolong QTc interval in healthy volunteers

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Repeated supratherapeutic dosing of strontium ranelate over 15 days does not prolong QT(c) interval in healthy volunteers.

AIMS The study was performed to assess the safety of strontium ranelate in accordance with the ICH, E14 guidelines for QT/QT(c) studies. Its primary objective was to compare supratherapeutic repeated dosing of strontium ranelate (4 g day⁻¹ for 15 days) with placebo on the largest time-matched mean QT(c) variation, from baseline to under treatment values, in healthy subjects. METHODS Ninety-si...

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Exenatide at therapeutic and supratherapeutic concentrations does not prolong the QTc interval in healthy subjects

AIMS Exenatide has been demonstrated to improve glycaemic control in patients with type 2 diabetes, with no effect on heart rate corrected QT (QTc ) at therapeutic concentrations. This randomized, placebo- and positive-controlled, crossover, thorough QT study evaluated the effects of therapeutic and supratherapeutic exenatide concentrations on QTc . METHODS Intravenous infusion was employed t...

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Bupivacaine extended release liposome injection does not prolong QTc interval in a thorough QT/QTc study in healthy volunteers.

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Lenalidomide at Therapeutic and Supratherapeutic Doses Does Not Prolong QTc Intervals in the Thorough QTc Study Conducted in Healthy Men

The effect of lenalidomide on the corrected QT (QTc) interval was evaluated in healthy men and extended to patients based on the lenalidomide concentration-QTc (C-QTc) relationship. A rigorous assessment of the effect of lenalidomide on QTc intervals was conducted in healthy volunteers who each received, in randomized order, a single oral dose of 10 mg lenalidomide, 50 mg lenalidomide, 400 mg m...

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A single supratherapeutic dose of vorinostat does not prolong the QTc interval in patients with advanced cancer.

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ژورنال

عنوان ژورنال: British Journal of Clinical Pharmacology

سال: 2012

ISSN: 0306-5251

DOI: 10.1111/j.1365-2125.2012.04190.x