安特尔与男性健康课件幻灯.ppt

* To determine the effect of food on the oral bioavailability of Andriol? Testocaps?, an open-label, two period, cross-over trial in 16 healthy postmenopausal women was performed. TU (80 mg) was administered with and without a standardized breakfast in a randomized order and a wash-out period of 7 days between treatments. Blood samples were collected to determine serum concentrations of testosterone using a GC-MS assay. Food had a major effect on the bioavailability of Andriol? Testocaps?. The maximum serum testosterone concentration (Cmax) occurred at 5.0 h after dosing and was 20 times higher when the preparation was administered to fed as compared to fasted subjects. A 13-fold increase in the area under the concentration versus time curve (AUC) of testosterone was shown in the fed state. This increase is likely to be due to increased solubilization and facilitation of lymphatic transport of TU as a result of lipid digestion and absorption of the co-administered food. Intake of Andriol? Testocaps? with food significantly enhances the bioavailability of testosterone as compared to the fasted state. Therefore, it is concluded that for proper absorption, Andriol? Testocaps? must be taken after a meal. Reference: Bagchus WM, Hust R, Maris F, Schnabel PG, Houwing NS. Important effect of food on the bioavailability of oral testosterone undecanoate. Pharmacotherapy 2003;23:319-325 * Treatment with Andriol? Testocaps? in hypogonadal men resulted in a quick increase of serum testosterone levels. Already after 3 days of treatment, average morning serum testosterone levels (before administration of Andriol? Testocaps?) were within the normal range for all four dose groups. Average trough morning serum testosterone levels remained within the normal range during 28 days of treatment with all four dose groups. The results suggest that with the 40-40-40 mg and 40-40-80 mg regimens trough serum testosterone levels were restored to levels within the lower normal range, whereas wit