抄録
The influence of lipids in the food on the bioavailability of nifedipine sustained-release granules (KB-1712P) was examined in healthy subjects.Each of seven male volunteers was given 15mg of nifedipine sustained-release granules with 100ml of water under two conditions, after a low-fat diet and high-fat diet.A crossover method was employed after a two-days washout period. Blood samples were drawn at time zero, and 1, 2, 3, 4, 6, 8, and 10 hours after dosing.Nifedipine assays in plasma were performed by high performance liquid chromatography (HPLC). The maximum plasma concentration of 80.4ng/ml was observed at 3 hours.A mean plasma level was 13.4ng/ml at 10 hours.The area under the concentration-time curve (AUC) from 0 to 10 hours, maximum plasma concentration (Cmax), mean residence time (MRT), absorption rate constant (Ka), and elimination rate constant (Ke) were not significantly altered by the content of fat in the diet.The mean time to peak level (Tmax) for low-fat and high-fat diets were 3.08hr and 2.33hr, respectively. These results indicate that under a meal containing about 30g and about 60g of fats per day this sustained-release granules is not changed in absorption.
