The lack effect of food on the bioavailability of nefazodone tablets.
Biopharm Drug Dispos
; 17(2): 135-43, 1996 Mar.
Article
en En
| MEDLINE
| ID: mdl-8907720
The objective of this study was to assess the effect of food on the pharmacokinetics of nefazodone (NEF). A group of 24 healthy adult male volunteers received a single 200 mg dose of NEF under fasting conditions as well as 5 min after a high-fat breakfast. There was a 1 week washout between treatments. Serial blood samples were collected for 48 h after dosing and assayed by a validated HPLC method for NEF and the metabolites hydroxynefazodone (HO-NEF), m-chlorophenylpiperazine (mCPP), and triazoledione (dione). The mean (SD) peak concentration (Cmax) for NEF was not affected by food and was 416 (220) ng mL-1 and 446 (271) ng mL-1 after the fed and fasted treatments, respectively. The median time to reach Cmax (Tmax) was also unaffected by food and was 2 h for both treatments. However, the mean (SD) area under the curve (AUC) was significantly reduced by food from 1815 (1017) ng h mL-1 to 1409 (695) ng h mL-1. Although there was an 18% decrease in NEF AUC when administered with food, food had no effect on Cmax and Tmax values for NEF, HO-NEF, mCPP or dione or AUC values for HO-NEF, mCPP, or dione, indicating that NEF can be administered without regard to meals.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Triazoles
/
Grasas de la Dieta
/
Antidepresivos de Segunda Generación
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Límite:
Adolescent
/
Adult
/
Humans
/
Male
Idioma:
En
Revista:
Biopharm Drug Dispos
Año:
1996
Tipo del documento:
Article
País de afiliación:
Estados Unidos
Pais de publicación:
Reino Unido