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drugset / Trial / NCT04683926

A Randomized Study Investigating Oral Desmetramadol Dose Proportionality and Food Effect In Normal Human Subjects

NCT04683926 ↗

Phase 1 Completed 24 enrolled Syntrix Biosystems, Inc. Celerion · collab National Institute on Drug Abuse (NIDA) · collab

RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of the study is to investigate in healthy human subjects how much desmetramadol (Omnitram) gets in the blood after different oral doses are taken with or without food.

Timeline

Start: 2021-01-08
Primary completion: 2021-01-18
Completion: 2021-01-18

Publications

Background Zebala JA, Searle SL, Webster LR, Johnson MS, Schuler AD, Maeda DY, Kahn SJ. Desmetramadol Has the Safety and Analgesic Profile of Tramadol Without Its Metabolic Liabilities: Consecutive Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Trials. J Pain. 2019 Oct;20(10):1218-1235. doi: 10.1016/j.jpain.2019.04.005. Epub 2019 Apr 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Desmetramadol	Small molecule	10 mg	Oral
Subject	Desmetramadol	Small molecule	20 mg	Oral
Subject	Desmetramadol	Small molecule	30 mg	Oral

Indications

No indication recorded.