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Abstract
Bioequivalence Study of Modified Release Formulations of Trimetazidine 35 mg MR Tablets in Healthy Thai Subjects: Single Dose under Fasting Condition, Single Dose Under Fed Condition and Multiple Dose Under Fed Condition.
Chuleegone Sornsuvit*, Wannakamol Sonsingh, Jutamas Jiaranaikulwanitch, Darunee Hongwiset, Songwut Yotsawimonwat, Peerapong Srifun, Manatchaya Toonkum, Parichat Salee and Kanokkarn Pinyopornpanish
Objective: This study aimed to determine the bioequivalence of trimetazidine dihydrochloride 35 mg modifiedrelease tablets between a trimetazidine test product and a reference product in healthy subjects.
Significance: Trimetazidine, available as a modified-release dosage form, is approved as an add-on therapy for the treatment of stable angina pectoris patients. Conducting multiple-dose Bioequivalence (BE) studies may be necessary for extended-release dosage forms, in addition to the standard single-dose fasting and non-fasting BE studies.
Methods: The bioequivalence assessment was conducted under three conditions: Single-dose under fasting condition (Study A), single dose under fed condition (Study B), and multiple-doses under fed condition (Study C). An open-label, randomized, two-treatment, two-period, two-sequence, crossover design was employed, with 24 healthy volunteers recruited for each condition. The concentrations of trimetazidine in plasma were measured using validated LC-MS/MS, and pharmacokinetic parameters were calculated to assess bioequivalence.
Results: For fasting and fed condition single-dose testing, the 90% CI for ratios of geometric means for Cmax ranged from 91.89% to 100.12% and 101.65% to 109.65%, respectively. The corresponding values for AUC0-t were 96.17% to 101.25% and 99.76% to 105.41%. In the multiple-dose fed condition, the 90% CI for Cmax,ss, Cτ,ss, and AUC(0-τ),ss were 100.11% to 108.68%, 96.43% to 102.26%, and 93.06% to 101.46%, respectively. All these values fell within the equivalent criteria of 80.00% to 125.00%.
Conclusion: Based on these results, it can be concluded that the two formulations of trimetazidine 35 mg modified-release tablets were found to be bioequivalent.
Published Date: 2024-02-09; Received Date: 2024-01-09