Bioequivalence of trimetazidine modified release tablet formulations assessed in Indonesian subjects

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Abstract

This study was conducted in order to compare the bioavailability of two modified release tablets containing 35 mg of trimetazidine. Twenty-four subjects were enrolled in a single center, randomized, single dose, open label, two-way crossover study with a one-week washout period. Plasma samples were collected up 48 hours following drug administration and trimetazidine was determined by liquid chromatography-tandem mass spectrometry (LCMS/ MS) method with turboionspray mode. Pharmacokinetic parameters used for bioequivalence assessment were AUC0-t, AUC0-∞ and Cmax. The 90% confidence intervals obtained by analysis of variance for AUC0-t, AUC0-∞ and Cmax were 94.89-105.15%, 94.85-105.23%, 93.31-107.36%, respectively. These results were all within the range of 80.00-125.00%. Bioequivalence between formulations was concluded both in terms of rate and extent of absorption. © 2013 Harahap Y, et al.

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CITATION STYLE

APA

Harahap, Y., Budi Prasaja, M. M., Lusthom, W., Hardiyanti, Azmi, F., Felicia, V., & Yusvita, L. Y. (2013). Bioequivalence of trimetazidine modified release tablet formulations assessed in Indonesian subjects. Journal of Bioequivalence and Bioavailability, 5(3), 117–120. https://doi.org/10.4172/jbb.1000144

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