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Bioequivalence Study of Two Formulations of 35mg Trimetazidine Modified Release Tablets in Healthy Thai Volunteers Under Fasting and Fed Conditions

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Author(s): Weerawadee Chandranipapongse | Somruedee Chatsiricharoenkul | Tullaya Ruangnapa | Suthathip Ngokpol | Korbtham Sathirakul | Piyapat Pongnarin | Supornchai Kongpatanakul

Journal: Journal of Bioequivalence & Bioavailability
ISSN 0975-0851

Volume: 3;
Issue: 3;
Start page: 52;
Date: 2011;
Original page

Keywords: Trimetazidine | Bioequivalence | Pharmacokinetics

ABSTRACT
Background: The generic product of trimetazidine, an anti-anginal agent, is currently available in Thailand.Bioequivalence study is used to compare rate and extent of absorption between generic and innovator’s products.Objective: To determine the bioavailability of two modified release tablets of 35mg trimetazidine dihydrochloride(Matenol® MR; generic product and Vastarel® MR; innovator’s product)Materials and methods: The study was conducted according to a single-dose, two-treatment, two-period, twosequencerandomized crossover design under fasting and fed conditions with a minimum of 7 days washout period.Twenty-four healthy Thai male and female volunteers were enrolled; however, only twenty-two subjects in the fastinggroup and twenty-three subjects in the fed group were completed the studies. For both conditions, each volunteerreceived a 35mg trimetazidine modified release tablet of both formulations. Every volunteers were obtained bloodsamples 16 times over a period of 24 hours after each oral administration.The trimetazidine plasma concentrationswere quantified using a validated method employing liquid chromatography with tandem mass spectrometry withthe lower limit of quantification of 0.25 ng/mL. All of the pharmacokinetic parameters were investigated using noncompartmentalanalysis model.Results: The 90% confidence interval of the geometric mean ratio of Cmax, AUC0-t and AUC0-∞ were withinthe equivalence criteria (80.00-125.00%) which were 105.53% (95.71%-116.36%), 104.28% (96.24%-112.98%,and 105.26% (96.61%-114.67%) under fasting condition and 110.21% (102.72%-118.25%), 101.95% (94.33%-119.19%), and 99.7% (91.18%-109.02%) under fed condition, respectively. No statistical differences of median Tmax(p>0.05) between two formulations in both conditions were observed. Furthermore, both preparations were welltolerated and had a few non-serious adverse events including nausea, dizziness, drowsiness and headache.Conclusion: These two trimetazidine products have comparable bioavailability.
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