| Food effect on the oral bioavailability of Manidipine: single dose, randomized, crossover study in healthy male subjects. | |
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MedLine Citation:
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PMID: 9725481 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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<0.01) but did not modify the rate of absorption (tmax unchanged, median = 1.5 h). Peak plasma concentration was also increased (from 6.2 to 7.8 ng/ml), but the difference was not statistically significant (p=0.18). Other pharmacokinetic parameters (apparent elimination half-life and mean residence time) remained unchanged. The increase in bioavailability of manidipine administered with food is related to its high lipophilicity and may be explained through a solubilization effect produced by food and bile secretions. |
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Authors:
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D Rosillon; A Stockis; G Poli; D Acerbi; R Lins; B Jeanbaptiste |
Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: European journal of drug metabolism and pharmacokinetics Volume: 23 ISSN: 0378-7966 ISO Abbreviation: Eur J Drug Metab Pharmacokinet Publication Date: 1998 Apr-Jun |
Date Detail:
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Created Date: 1998-11-03 Completed Date: 1998-11-03 Revised Date: 2011-02-02 |
Medline Journal Info:
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Nlm Unique ID: 7608491 Medline TA: Eur J Drug Metab Pharmacokinet Country: SWITZERLAND |
Other Details:
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Languages: eng Pagination: 197-202 Citation Subset: IM |
Affiliation:
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Bio-Pharma, Clinical Pharmacology, Wavre, Belgium. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Antihypertensive Agents / metabolism, pharmacokinetics Biological Availability Calcium Channel Blockers / adverse effects, metabolism, pharmacokinetics Dihydropyridines / adverse effects, metabolism, pharmacokinetics* Double-Blind Method Food-Drug Interactions* Humans Male |
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Reg. No./Substance:
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0/Antihypertensive Agents; 0/Calcium Channel Blockers; 0/Dihydropyridines; 89226-50-6/manidipine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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