Omnitram Pharmacokinetic Study In Healthy Volunteers

NCT02205554 ↗

Phase 1 Completed 43 enrolled Syntrix Biosystems, Inc. National Institute on Drug Abuse (NIDA) · collab

RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study is to compare the safety, pharmacokinetic properties (the absorption, distribution and excretion), and analgesic activity of Omnitram (10 mg tablets), Tramadol (Ultram, 50 mg tablet) following oral administration of 9 doses healthy subjects.

Timeline

Start: 2014-08
Primary completion: 2014-10
Completion: 2014-10

Publications

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
Comparator	Desmetramadol	Small molecule	20 mg	Oral
Comparator	Tramadol	Other / unclassified	50 mg	Oral

Indications

No indication recorded.