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 language | English |
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Pages (from-to) | 117-120 |
Number of pages | 4 |
Journal | Journal of Bioequivalence and Bioavailability |
Volume | 5 |
Issue number | 3 |
DOIs | |
Publication status | Published - 6 Jun 2013 |
Keywords
- Angina pectoris
- Bioequivalence
- Modified release
- Pharmacokinetic
- Trimetazidine