British journal of clinical pharmacology
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Br J Clin Pharmacol · Feb 2017
Randomized Controlled Trial Comparative StudyThorough QT study of the effect of intravenous amisulpride on QTc interval in Caucasian and Japanese healthy subjects.
The D2 /D3 antagonist amisulpride has shown promising efficacy against postoperative nausea and vomiting (PONV) at low doses. We investigated whether intravenous amisulpride has an effect on the QTc interval in a formal Thorough QT study (TQT). ⋯ Amisulpride has a plasma concentration-dependent effect on the QTc interval. The proposed therapeutic dose for management of PONV does not lead to a prolongation of QTcF above the threshold of regulatory concern, while such effect could not be excluded for the supratherapeutic dose.