Tramadol Hydrochloride at Steady State Lacks Clinically Relevant QTc Interval Increases in Healthy Adults

Clinical Pharmacology in Drug Development
Joseph MassarellaSergio Fonseca

Abstract

We evaluated the effects of therapeutic and supratherapeutic doses of tramadol hydrochloride on the corrected QT (QTc) interval in healthy adults (aged 18-55 years) in a randomized, phase I, double-blind, placebo- and positive-controlled, multiple-dose, 4-way crossover study. Participants were randomized to receive 1 of 4 treatments (A-D), 1 each in 4 treatment periods (1-4), separated by a washout period (7-15 days). Treatment A comprised tramadol 400 mg (therapeutic dose) on days 1 through 3, tramadol 100 mg and moxifloxacin-matched placebo on day 4, and placebo on all 4 days. Treatment B comprised tramadol 600 mg (supratherapeutic dose) on days 1 through 3, and tramadol 150 mg and moxifloxacin-matched placebo on day 4. Treatment C comprised placebo on days 1 through 4 and moxifloxacin-matched placebo on day 4. Treatment D comprised placebo on days 1 through 4 and moxifloxacin 400 mg on day 4. Of 68 participants enrolled, 57 (83.8%) completed the study. Both therapeutic and supratherapeutic doses of tramadol were shown to be noninferior to placebo regarding their effect on QTc prolongation. Sixty-one of 68 (89.7%) participants reported at least 1 treatment-emergent adverse event (mild); nausea was the most frequently reported...Continue Reading

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Citations

Jun 17, 2020·Pharmacogenomics·Miriam Saiz-RodríguezFrancisco Abad-Santos
Jan 27, 2021·Journal of Cardiothoracic and Vascular Anesthesia·Naoko NiimiKatherine Zaleski
Jul 1, 2020·Drug Metabolism and Personalized Therapy·Mahnaz AhmadimaneshMahmoud Ghazi-Khansari
Jul 3, 2021·Therapeutic Advances in Drug Safety·Montserrat GarcíaCarmelo Aguirre

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Methods Mentioned

BETA
Assay
genotyping

Clinical Trials Mentioned

NCT02307864

Software Mentioned

WinNonlin Professional
SAS
Phoenix

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