Effect of menthol on the pharmacokinetics and pharmacodynamics of felodipine in healthy subjects |
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Authors: | Ayse Gelal Dilara Balkan Deniz Ozzeybek Yusuf C. Kaplan Selma Gurler Hulya Guven Neal L. Benowitz |
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Affiliation: | (1) Department of Pharmacology, Dokuz Eylul University Medical Faculty, Inciralti, 35340 Izmir, Turkey;(2) Department of Anesthesiology, Dokuz Eylul University Medical Faculty, Inciralti, 35340 Izmir, Turkey;(3) Department of Statistics, Dokuz Eylul University Faculty of Arts and Sciences, Kaynaklar Campus, 35160 Izmir, Turkey;(4) University of California, Box 1220, San Francisco, CA 94143-1220, USA |
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Abstract: | Objectives The present study was undertaken to determine whether menthol affects the metabolism of and pharmacological responses to the calcium channel antagonist felodipine in people.Methods Eleven healthy subjects (ten female, one male) participated in a randomized, double-blind, two-way crossover study, comparing the kinetics and effects of a single oral dose of felodipine ER tablet (Plendil, 10 mg) with menthol (test) or placebo (reference) capsules. Ten subjects completed the study. At the beginning of the study, a 10-mg felodipine ER tablet and a 100-mg menthol or placebo capsule were given. During the 2nd, 5th and 7th hours of the study, 50, 25 and 25 mg menthol or placebo capsules were given, respectively. Blood samples and cardiovascular measurements were obtained at frequent intervals. Serum felodipine and dehydrofelodipine concentrations were determined by means of gas chromatography/mass spectrometry.Results Pharmacokinetic parameters of felodipine and dehydrofelodipine (AUC0–24, Cmax, tmax, dehydrofelodipine/felodipine AUC0–24 ratio) were not markedly changed with menthol coadministration. Only eight female subjects cardiovascular data were included in the analysis because of technical problems during the measurements. There were no statistically significant differences in blood pressures and heart rates between the two treatments.Conclusions We conclude that the pharmacokinetics and pharmacodynamics of felodipine were essentially unaltered by menthol. |
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Keywords: | Felodipine Menthol Monoterpenes Essential oils |
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