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Effect of High‐Fat Breakfast and Moderate‐Fat Evening Meal on the Pharmacokinetics of Vardenafil, an Oral Phosphodiesterase‐5 Inhibitor for the Treatment of Erectile Dysfunction
Abstract
The effects of food on the pharmacokinetics of vardenafil were examined in 25 healthy adult males. Single‐dose vardenafil 20 mg was administered in a randomized four‐way crossover design after an overnight fast (at 8 a.m.), after consumption of a high‐fat breakfast (at 8 a.m.), on an empty stomach (at 6 p.m.), and after a typical moderate‐fat evening meal (at 6 p.m.). Serial blood samples were analyzed for vardenafil and metabolite (M1) levels. When administered after an overnight fast and after a high‐fat breakfast, vardenafil geometric mean Cmax was 17.14 and 14.0 μg/L, respectively, and AUC was 66.78 and 67.09 μg•h/L, respectively; the median tmax was 1 hour under fasting conditions and 2 hours with consumption of high‐fat breakfast. When administered in the evening on an empty stomach and after a moderate‐fat meal, vardenafil geometric mean Cmax was 14.22 and 13.04 μg/L, respectively, and AUC was 51.97 and 59.12 μg•h/L, respectively. The median tmax was 1 hour after fasting or a moderate‐fat meal in the evening. All treatments were well tolerated. Thus, while a high‐fat meal may alter Cmax slightly and delay the absorption up to 1 hour, a moderate‐fat meal has no clinically relevant effect on vardenafil pharmacokinetics. Dosage changes are not warranted based on the wide therapeutic index and the efficacy observed with vardenafil in Phase III studies that were not restricted with respect to food.
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“In addition, in the presence of high-fat food, absorption of sildenafil and vardenafil may be delayed; however, the rate and extent of tadalafil absorption are unaffected by highfat food.”
From Phosphodiesterase type 5 inhibitor differentiation based on selectivity, pharmacokinetic, and efficacy profiles (2004) · cites this paper as [9]
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“Similarly, taking vardenafil with a highfat meal decreases the C max ranging from 18 to 50% and delays T max by about 1 h (Fig. 2). 9”
From Phosphodiesterase type 5 inhibitor differentiation based on selectivity, pharmacokinetic, and efficacy profiles (2004) · cites this paper as [9]
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Research works printed but not linked: 14
- 10.1056/NEJM200006153422407 · DOI · Paper page
- 10.1016/S0149-2918(01)80027-8 · DOI
- 10.2165/00002512-200219030-00005 · DOI
- Gbekor E, 2002, Phosphodiesterase‐5 inhibitor profiles against all human phosphodiesterase families: implications for use as pharmacological tools, J Urology, 167, 967
- Porst H, 2001, Vardenafil demonstrated similar efficacy and tolerability among older and younger patients with marginal differences in PK characteristics between age groups, Int J Impot Res, 13, 45
- 10.1002/j.1939-4640.2002.tb02332.x · DOI · Paper page
- Goldstein I, 2001, Investigators of the Vardenafil Diabetes Phase III Study: Vardenafil demonstrates improved erectile function in diabetic men with erectile dysfunction, Int J Impot Res, 13, S64
- 10.1016/S1569-9056(02)80591-7 · DOI
- 10.2165/00003088-199936030-00004 · DOI · Paper page
- 10.2165/00003088-199937030-00003 · DOI · Paper page
- Rowland M, 1995, Clinical Pharmacokinetics: Concepts and Applications
- 10.1201/b14095 · DOI
- Bischoff E, 2001, Inhibition of human recombinant PDE isoenzymes by metabolites of BAY 38–9456 and their in vivo exposure and relative efficacies in humans
- U.S. Department of Health and Human Services, 2001, Food and Drug Administration, Center for Drug Evaluation and Research (CDER): Guidance for Industry: Food‐Effect Bioavailability and Bioequivalence Studies: Study Design, Data Analysis, and Labeling
Cited by
Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation
Hatzimouratidis, K., Amar, E., Eardley, I., Giuliano, F., Hatzichristou, D., Montorsi, F., Vardi, Y., & Wespes, E. (2010) · European Urology · doi:10.1016/j.eururo.2010.02.020 · Cited by 1,223
Seftel, A. D. (2004) · Clinical Cardiology · doi:10.1002/clc.4960271305 · Cited by 79
Treatment Options for Erectile Dysfunction
Brant, W. O., Bella, A. J., & Lue, T. F. (2007) · Endocrinology and Metabolism Clinics of North America · doi:10.1016/j.ecl.2007.02.001 · Cited by 51
Metadata
- Authors
- Rajagopalan, P., Mazzu, A., Xia, C., Dawkins, R., & Sundaresan, P.
- Venue
- The Journal of Clinical Pharmacology
- Publisher
- Wiley
- Published
- 2003-03
- Volume
- 43
- Issue
- 3
- Pages
- 260-267
- ISSN
- 0091-2700
- 1552-4604
- Cited by
- 83
- References
- 0
- Language
- en
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- Rajagopalan, P., Mazzu, A., Xia, C., Dawkins, R., & Sundaresan, P. (2003). Effect of High‐Fat Breakfast and Moderate‐Fat Evening Meal on the Pharmacokinetics of Vardenafil, an Oral Phosphodiesterase‐5 Inhibitor for the Treatment of Erectile Dysfunction. The Journal of Clinical Pharmacology. https://doi.org/10.1177/0091270002250604
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