Evaluation of the Pharmacokinetics, Bioequivalence, and Safety of Two Preparations of 20-mg Trimetazidine in Healthy Chinese Subjects.

In this study, we assessed the pharmacokinetics, safety, and bioequivalence of trimetazidine tablets from 2 different manufacturers in healthy Chinese individuals under both fasting and fed conditions. Twenty-eight healthy Chinese volunteers were included in each fasting and fed group. They were randomly assigned to fasting and fed arms in a single-center, randomized, open-label, crossover trial with a 2-period, 2-sequence design. Plasma trimetazidine levels were determined using liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters were determined using a nonatrioventricular model. The pharmacokinetic parameters were obtained by the concentration-time profiles, including the area under the plasma concentration-time curve from time 0 to 24 hours, area under the concentration-time curve from time 0 to infinity, maximum concentration, time to achieve maximum concentration, and elimination half-life. Both trimetazidine preparations were bioequivalent under fasting and fed states, with all parameters within the acceptable limits. All recorded adverse events were mild. Overall, the test trimetazidine formulation was bioequivalent to the reference formulation and safe for use in healthy Chinese subjects in both the fasting and fed states.