Bioequivalence of trimetazidine modified release tablet formulations assessed in Indonesian subjects

Yahdiana Harahap; M. M. Budi Prasaja; Windy Lusthom; Hardiyanti; Fahmi Azmi; Vita Felicia; Lia Yumi Yusvita

doi:10.4172/jbb.1000144

Bioequivalence of trimetazidine modified release tablet formulations assessed in Indonesian subjects

Yahdiana Harahap, M. M. Budi Prasaja, Windy Lusthom, Hardiyanti, Fahmi Azmi, Vita Felicia, Lia Yumi Yusvita

Department of Pharmacy

Research output: Contribution to journal › Article

1 Citation (Scopus)

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 AUC_0-t, AUC_0-∞ and C_max. The 90% confidence intervals obtained by analysis of variance for AUC_0-t, AUC_0-∞ and C_max 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.

Original language	English
Pages (from-to)	117-120
Number of pages	4
Journal	Journal of Bioequivalence and Bioavailability
Volume	5
Issue number	3
DOIs	https://doi.org/10.4172/jbb.1000144
Publication status	Published - 6 Jun 2013

Keywords

Angina pectoris
Bioequivalence
Modified release
Pharmacokinetic
Trimetazidine

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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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title = "Bioequivalence of trimetazidine modified release tablet formulations assessed in Indonesian subjects",

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.",

keywords = "Angina pectoris, Bioequivalence, Modified release, Pharmacokinetic, Trimetazidine",

author = "Yahdiana Harahap and {Budi Prasaja}, {M. M.} and Windy Lusthom and Hardiyanti and Fahmi Azmi and Vita Felicia and Yusvita, {Lia Yumi}",

year = "2013",

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AU - Harahap, Yahdiana

AU - Budi Prasaja, M. M.

AU - Lusthom, Windy

AU - Hardiyanti,

AU - Azmi, Fahmi

AU - Felicia, Vita

AU - Yusvita, Lia Yumi

PY - 2013/6/6

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N2 - 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.

AB - 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.

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