Document Detail


Pharmacokinetic studies with a dual-release formulation of levodopa, a novel principle in the treatment of Parkinson's disease.
MedLine Citation:
PMID:  9520073     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The objectives of the two studies reported here were the investigation of the influence of tablet breaking and food on the pharmacokinetics of levodopa and 3-O-methyldopa (3-OMD) after administration of a new levodopa/benserazide formulation with a biphasic drug delivery profile (Madopar DR). Both studies had an open-label, randomised, two-way crossover design and were conducted in 12 healthy young subjects. The pharmacokinetics of levodopa and 3-OMD after one intact or two halved tablets were very similar with average Cmax and tmax 1.9 mg x l(-1) and 1.2 h, respectively. Administration of the formulation after a standard breakfast did not influence the extent of levodopa absorption but increased the absorption rate. Cmax and tmax were on average 2.1 mg x l(-1) and 1.3 h, respectively, in the fed condition and 1.5 mg x l(-1) and 2.5 h in the fasted condition. The presence of food did not markedly affect the plateau in levodopa levels between about 1 and 3 h after intake. In conclusion, the release characteristics in healthy subjects of the new levodopa/benserazide formulation are influenced only to a minor extent by concomitant intake of food or by tablet breaking.
Authors:
J Dingemanse; C H Kleinbloesem; C Crevoisier; G Lankhaar; U E Gasser
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  European neurology     Volume:  39     ISSN:  0014-3022     ISO Abbreviation:  Eur. Neurol.     Publication Date:  1998  
Date Detail:
Created Date:  1998-05-27     Completed Date:  1998-05-27     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0150760     Medline TA:  Eur Neurol     Country:  SWITZERLAND    
Other Details:
Languages:  eng     Pagination:  119-24     Citation Subset:  IM    
Affiliation:
Clin-Pharma Research Ltd., Birsfelden, Switzerland. cprch@datacomm.ch
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Antiparkinson Agents / adverse effects,  pharmacokinetics,  therapeutic use*
Cross-Over Studies
Delayed-Action Preparations
Female
Food
Humans
Levodopa / adverse effects,  pharmacokinetics,  therapeutic use*
Male
Parkinson Disease / drug therapy*,  metabolism
Tablets
Tyrosine / analogs & derivatives*,  pharmacokinetics
Chemical
Reg. No./Substance:
0/Antiparkinson Agents; 0/Delayed-Action Preparations; 0/Levodopa; 0/Tablets; 55520-40-6/Tyrosine; 7636-26-2/3-methoxytyrosine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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