Effect of Two Different Meals on Bioavailability of Nilvadipine in Healthy Volunteers

Abstract

The effect of two different meals on the bioavailability of nilvadipine, a new antihypertensive and antianginal drug, was examined in 16 healthy male volunteers in two separate studies. In each study of eight subjects in a Latin-square, two-way crossover design, two groups of four subjects each were given a single 6-mg oral dose of nilvadipine after overnight fasting or 30 minutes after a 464- or 748-kcal meal. There were no significant differences in the area under the plasma concentration-time curve or the maximum plasma concentration between the fasting and fed states for either meal. Although the time to reach the maximum plasma concentration was about the same after a 464-kcal meal and after fasting, it increased slightly but significantly after a 748-kcal meal, indicating possible delay in drug absorption after meals. These studies showed that the extent of bioavailability of nilvadipine appears to be little affected in the presence of food. Although a possible delay in the onset of absorption would occur, such a delay may not have any therapeutic importance in chronic therapy.

Food effect on the oral bioavailability of Manidipine: single dose, randomized, crossover study in healthy male subjects

“…The same findings were observed for the other dihydropyridine calcium antagonists as benidipine (16), felodipine (17), and nisoldipine (16), showing the same lipophilicity as manidipine (18). On the other hand, no significant food effect on the extent of absorption was observed for other less lipophilic dihydropyridine calcium antagonists as nifedipine (19,20,21,22,23), amlodipine (24,25,26), isradipine (27), and nilvadipine (28).…”