Avenue therapeutics announces publication of iv tramadol phase 1 clinical data in clinical pharmacology in drug development
Avenue therapeutics, inc. announced that its phase 1 data on intravenous (iv) tramadol has been published in the peer-reviewed journal clinical pharmacology in drug development. based on the results of the study, avenue chose the iv tramadol 50 mg dosing regimen for phase 3 development. the objective of this phase 1, open-label, single investigational center, three-treatment, three-period, multidose crossover study was to compare the pharmacokinetics of two novel iv tramadol dosing regimens to oral tramadol 100 mg given every six hours, the highest approved oral dosage in the united states. compared to the oral regimen, iv tramadol 50 mg administered at hours 0, 2, and 4 and every 4 hours thereafter reached initial tramadol peak serum concentration (cmax) more rapidly, while resulting in similar overall steady-state cmax and area under the plasma concentration–time curve, and that the primary metabolite, m1, had lower area under the plasma concentration–time curve and cmax than for the oral regimen. the iv tramadol 50 mg dosing regimen was well tolerated, with adverse event profiles consistent with the known pharmacological effects of tramadol.
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