Department of Pharmaceutical Care, Chiang Mai University, Chiang Mai, 50200, Thailand
Research Article
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.
Author(s): 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-sequ.. View more»