THE LACK EFFECT OF FOOD ON THE BIOAVAILABILITY OF NEFAZODONE TABLETS

The objective of this study was to assess the effect of food on the ph armacokinetics of nefazodone (NEF). A group of 24 healthy adult male v olunteers received a single 200 mg dose of NEF under fasting condition s as well as 5 min after a high-fat breakfast. There was a I week wash out between treatments. Serial blood samples were collected for 48 h a fter dosing and assayed by a validated HPLC method for NEF and the met abolites hydroxynefazodone (HO-NEF), m-chlorophenylpiperazine (mCPP), and triazoledione (dione). The mean (SD) peak concentration (C-max) fo r 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 medi an time to reach C-max (T-max) was also unaffected by food and was 2 h for both treatments. However, the mean (SD) area under the curve (AUG ) was significantly reduced by food from 1815 (1017)ng h mL(-1) to 140 9 (695) ng h mL(-1). Although there was an 18% decrease in NEF AUC whe n administered with food, food had no effect on C-max and T-max values for NEF, HO-NEF, mCPP or dione or AUC values for HO-NEF, mCPP, or dio ne, indicating that NEF can be administered without regard to meals.