Pharmacokinetic Drug Interaction Between Pregabalin and Thioctic Acid.

Phase 1 Completed 42 enrolled Unimed Pharmaceuticals

RandomizedCrossoverOpen-label

Summary

A randomized, open-label, six-sequence, three-period, three-treatment, multiple dosing clinical trial to investigate the pharmacokinetic drug interaction between Pregabalin and Thioctic acid after oral administration in healthy male volunteers.

Timeline

Start: 2013-02
Primary completion: 2013-07
Completion: 2013-08

Publications

Rhee SJ, Lee H, Ahn LY, Lim KS, Yu KS. Lack of a Clinically Significant Pharmacokinetic Interaction Between Pregabalin and Thioctic Acid in Healthy Volunteers. Clin Ther. 2018 Oct;40(10):1720-1728.e2. doi: 10.1016/j.clinthera.2018.08.016. Epub 2018 Sep 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	300 mg	Oral
Subject	Thioctic Acid	Unknown	600 mg	Oral

Indications

No indication recorded.