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Evaluation of the Pharmacokinetic Interaction between Candesartan Cilexetil and Felodipine

Author(s): Eduardo Abib Junior | Luciana Fernandes Duarte | Fabio Proença Barros

Journal: Journal of Bioequivalence & Bioavailability
ISSN 0975-0851

Volume: 3;
Issue: 1;
Start page: 005;
Date: 2011;
Original page

Keywords: Candesartan | Felodipine | Biological availability | Pharmacokinetics | Chromatography | Bioequivalence

The study was performed to evaluate the pharmacokinetic interaction of test formulation of candesartan 16 mgtablet and felodipine extended release 5 mg tablet together in a combination package, comparing with the fastingperiod intake of commercial formulations of both Atacand® 16 mg tablet and Splendil® extended release 5 mgtablet (Test formulation and reference formulation from AstraZeneca, Brazil) in 36 volunteers of both sexes. Thestudy was conducted open with randomized three period crossover design and a one week wash out period. Thecandesartan and felodipine were analyzed by LC-MS-MS. The mean ratio of parameters Cmax and AUC0-t and 90%confidence intervals of correspondents were calculated to determine the pharmacokinetic interaction. Geometricmean of candesartan exposure together in a combination package felodipine individual percent ratio was 102.51%AUC0-t and 110.40% for Cmax. The 90% confidence intervals were 90.00 - 116.77% and 93.94 - 129.74%, respectively.Geometric mean of felodipine exposure together in a combination package candesartan individual percent ratio was102.69% AUC0-t and 96.17% for Cmax. The 90% confidence intervals were 89.46 - 117.88% and 82.07 - 112.69%,respectively. The major variable in this respect, AUC, was not signicantly affected by felodipine and candesartan withconcomitant administration. The Cmax of candesartan was not signicantly affected by co-administration of felodipine.Based on these data and in presence in the market of isolated candersatana and felodipino formularizations usedin combination in medical practice, it is concluded that there are no risk with concomitant administration betweenfelodipine and candesartan.
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