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- Title
Effect of food on the pharmacokinetics of the oral phosphodiesterase 5 inhibitor udenafil for the treatment of erectile dysfunction.
- Authors
Tae-Eun Kim; Bo-Hyung Kim; Jung-Ryul Kim; Kyoung Soo Lim; Jang Hee Hong; Kyu-pyo Kim; Hwa-Sook Kim; Sang-Goo Shin; In-Jin Jang; Kyung-Sang Yu
- Abstract
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Udenafil is a newly marketed phosphodiesterase type 5 (PDE5) inhibitor. • Udenafil is safe and well tolerated in healthy subjects, and effective as treatment for erectile dysfunction. • The effect of food on the pharmacokinetics of PDE5 inhibitors varies. WHAT THIS STUDY ADDS • This is the first study to determine the effect of food on the pharmacokinetics of udenafil. • Food generally does not affect the bioavailability of udenafil, although a low-fat diet shows a tendency to decreases the absorption rate of udenafil. AIMS Udenafil is a cyclic guanosine 3′,5′-monophosphate-specific phosphodiesterase type 5 (PDE5) inhibitor developed for the treatment of erectile dysfunction. The aim was to evaluate the effect of food on the pharmacokinetics of udenafil. METHODS An open, randomized, three-way crossover study was conducted. Fifteen healthy male volunteers received a single 200-mg oral dose of udenafil while fasting, after a low-fat meal, and after a high-fat meal separated by 7-day washout periods. Serial blood samples were taken up to 48 h after oral administration. RESULTS Under fasting conditions, udenafil was rapidly absorbed and tmax was observed typically 1.5 h after administration. The mean tmax values after a low-fat meal and a high-fat meal were 2.6 and 2.1 h, respectively. The ratios (90% confidence intervals) of the geometric means compared with the fasting condition for Cmax and AUClast were 0.79 (0.70, 0.90) and 0.96 (0.89, 1.03) in the low fat-fed condition, respectively, and 1.01 (0.89, 1.15) and 1.03 (0.96, 1.11), respectively, in the high fat-fed condition. CONCLUSIONS The tmax of udenafil was delayed under the fed conditions. However, although the Cmax was reduced by approximately 21% in the low fat-fed state, overall bioavailability was not affected when taken with food.
- Subjects
FOOD; PHARMACOKINETICS; PHOSPHODIESTERASES; IMPOTENCE; PHARMACOLOGY
- Publication
British Journal of Clinical Pharmacology, 2009, Vol 68, Issue 1, p43
- ISSN
0306-5251
- Publication type
Article
- DOI
10.1111/j.1365-2125.2009.03404.x