Pharmacokinetics and safety of a fixed-dose combination of pregabalin and thioctic acid in healthy volunteers: a randomized, open-label, phase 1 crossover study

In this single-dose, Phase 1 trial in healthy volunteers, co-administration of PGB and ALA did not result in clinically significant pharmacokinetic interactions and was well tolerated. These findings provide preliminary pharmacokinetic evidence to support further clinical evaluation in patients with PDN.