Publication: Bioequivalence study of two formulations of 35mg trimetazidine modified release tablets in healthy thai volunteers under fasting and fed conditions
Issued Date
2011-06-16
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ISSN
09750851
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2-s2.0-79958719757
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Mahidol University
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SCOPUS
Bibliographic Citation
Journal of Bioequivalence and Bioavailability. Vol.3, No.3 (2011), 52-55
Suggested Citation
Weerawadee Chandranipapongse, Somruedee Chatsiricharoenkul, Tullaya Ruangnapa, Suthathip Ngokpol, Korbtham Sathirakul, Piyapat Pongnarin, Supornchai Kongpatanakul Bioequivalence study of two formulations of 35mg trimetazidine modified release tablets in healthy thai volunteers under fasting and fed conditions. Journal of Bioequivalence and Bioavailability. Vol.3, No.3 (2011), 52-55. Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/12808
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Title
Bioequivalence study of two formulations of 35mg trimetazidine modified release tablets in healthy thai volunteers under fasting and fed conditions
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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, two sequence randomized 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 fasting group and twenty-three subjects in the fed group were completed the studies. For both conditions, each volunteer received a 35mg trimetazidine modified release tablet of both formulations. Every volunteers were obtained blood samples 16 times over a period of 24 hours after each oral administration. The trimetazidine plasma concentrations were quantified using a validated method employing liquid chromatography with tandem mass spectrometry with the lower limit of quantification of 0.25 ng/mL. All of the pharmacokinetic parameters were investigated using noncompartmental analysis model. Results: The 90% confidence interval of the geometric mean ratio of C max , AUC 0-t and AUC 0-∞ were within the 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 well tolerated and had a few non-serious adverse events including nausea, dizziness, drowsiness and headache. Conclusion: These two trimetazidine products have comparable bioavailability. © 2011 Chandranipapongse W, et al.