Journal
CLINICAL THERAPEUTICS
Volume 40, Issue 10, Pages 1720-1728Publisher
ELSEVIER
DOI: 10.1016/j.clinthera.2018.08.016
Keywords
drug interaction; pharmacokinetics; pregabalin; thioctic acid
Categories
Ask authors/readers for more resources
Purpose: Pregabalin and thioctic acid are likely to be used concomitantly for the treatment of painful diabetic neuropathy. In this study, the pharmacokinetic interaction between pregabalin and thioctic acid was investigated at steady state. Methods: A randomized, open-label, 6-sequence, 3-period, 3-treatment crossover study was conducted in 42 healthy male volunteers. The volunteers randomly received pregabalin 300 mg BID for 6 times, thioctic acid 600 mg once daily for 3 times, or the combination of pregabalin and thioctic acid. Serial blood samples were collected up to 24 hours after the last dosing in each period. Pharmacokinetic parameters were calculated by using noncompartmental analysis methods. Findings: The mean concentration-time curves were similar between each drug alone and in combination with the other drug. The 90% CIs of the geometric mean ratios with and without the co-administered drug for C-max at steady state and AUC during the dosing interval were well within the conventional bioequivalence range of 0.8 to 1.25, except for C-max at steady state for thioctic acid, which barely exceeded only the lower bound (0.78-1.15). Co-administered pregabalin and thioctic acid was well tolerated. (C) 2018 Elsevier Inc. All rights reserved.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available