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

Research output: Contribution to journalArticle

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 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.

Original languageEnglish
Pages (from-to)117-120
Number of pages4
JournalJournal of Bioequivalence and Bioavailability
Volume5
Issue number3
DOIs
Publication statusPublished - 6 Jun 2013

Keywords

  • Angina pectoris
  • Bioequivalence
  • Modified release
  • Pharmacokinetic
  • Trimetazidine

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