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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 treatment‐emergent adverse event. Summarizing, tramadol at doses up to 600 mg/day did not cause clinically relevant QTc interval prolongation in healthy adults.

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