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

The effect of food on the oral bioavailability of a manidipine 20 mg tablet was studied after a single administration in 12 male healthy subjects. The clinical trial was conducted as an open, randomised, crossover study. In two different administration sessions, the subjects received a 20 mg manidip...

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Bibliographic Details
Published in:European journal of drug metabolism and pharmacokinetics 1998-04, Vol.23 (2), p.197-202
Main Authors: ROSILLON, D, STOCKIS, A, POLI, G, ACERBI, D, LINS, R, JEANBAPTISTE, B
Format: Article
Language:English
Subjects:
Adult
Antihypertensive agents
Antihypertensive Agents - metabolism
Antihypertensive Agents - pharmacokinetics
Biological and medical sciences
Biological Availability
Calcium Channel Blockers - adverse effects
Calcium Channel Blockers - metabolism
Calcium Channel Blockers - pharmacokinetics
Cardiovascular system
Dihydropyridines - adverse effects
Dihydropyridines - metabolism
Dihydropyridines - pharmacokinetics
Double-Blind Method
Food-Drug Interactions
Humans
Male
Medical sciences
Pharmacology. Drug treatments
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Summary:The effect of food on the oral bioavailability of a manidipine 20 mg tablet was studied after a single administration in 12 male healthy subjects. The clinical trial was conducted as an open, randomised, crossover study. In two different administration sessions, the subjects received a 20 mg manidipine tablet either in the fasting state or after a standardized breakfast. Plasma samples were collected before and at different times after each administration for up to 24 h. The concentrations of manidipine and its pyridine metabolite (M-XIII metabolite) were determined by HPLC with coulometric detection. The tolerability of manidipine was good. Only two cases of mild headache, one with each treatment, were reported. Food significantly improved the absorption, with an increase in AUC from 19.1 to 27.2 ng.h/ml (geometric mean, p
ISSN:0378-7966
2107-0180
DOI:10.1007/BF03189339