Assessment of the Pharmacokinetics of a Sustained Release Formulation of a Tramadol/Acetaminophen Combination

Phase 1 Completed 24 enrolled Yungjin Pharm. Co., Ltd. Chonbuk National University Hospital · collab

RandomizedCrossoverOpen-labelOther

Summary

1. Objective: To evaluate the pharmacokinetic profiles of an SR 75 mg tramadol/650 mg acetaminophen formulation compared with an immediate release (IR) 37.5 mg tramadol/325 mg acetaminophen formulation after a single dose and at steady state 2. Subjects: Healthy subject 3. Methods: A phase I study to evaluate the pharmacokinetic sustained release and immediate release treatment profiles at steady state.

Timeline

Start: 2012-01
Primary completion: 2012-05
Completion: 2012-05

Publications

Im YJ, Jeon JY, Kim EY, Kim Y, Oh DJ, Yoo JS, Shin DH, Chae SW, Kim MG. An assessment of the pharmacokinetics of a sustained-release formulation of a tramadol/acetaminophen combination in healthy subjects. Clin Ther. 2015 Feb 1;37(2):376-89. doi: 10.1016/j.clinthera.2014.12.007. Epub 2015 Jan 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	325 mg	Oral
Subject	Acetaminophen	Small molecule	650 mg	Oral
Subject	Tramadol	Other / unclassified	37.5 mg	Oral
Subject	Tramadol	Other / unclassified	75 mg	Oral

Indications

No indication recorded.