Linked Life Data

8140046

Source:http://linkedlifedata.com/resource/pubmed/id/8140046

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
1994-4-26
pubmed:abstractText
The influence of a fat-rich meal on the pharmacokinetics of cyclosporine from a new oral formulation (Sandimmune Neoral) was compared in a randomized, four-way crossover study to the currently marketed formulation (Sandimmune) in 24 healthy male volunteers. Single oral doses of 300 mg Sandimmune and 180 mg Sandimmune Neoral were each administered once under fasting conditions and once 30 min after starting a high-fat meal. Serial blood samples were obtained over a 48-hr period after each administration, and whole-blood cyclosporine concentrations were determined by a specific monoclonal radioimmunoassay method. Food had a marked effect on cyclosporine absorption from Sandimmune manifested by a nearly doubled time to reach the peak concentration and a 37% increase in the area under the curve. This was associated with significant elevations in subsequent whole-blood cyclosporine concentrations compared to the fasting administration. For Sandimmune Neoral the influence was less pronounced. The maximum concentration was decreased by 26%, without a relevant change in the time to reach the peak; the area under the curve showed a slight reduction of 15%. The relatively minor influence of a fat-rich meal on the absorption of cyclosporine from Sandimmune Neoral is advantageous when individualizing a dosage regimen under clinical and outpatient administration conditions.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jan
pubmed:issn
0724-8741
pubmed:author
pubmed:issnType
Print
pubmed:volume
11
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
151-5
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed:year
1994
pubmed:articleTitle
Influence of a fat-rich meal on the pharmacokinetics of a new oral formulation of cyclosporine in a crossover comparison with the market formulation.
pubmed:affiliation
Department of Human Pharmacology, Sandoz Pharma, Ltd., Basle, Switzerland.
pubmed:publicationType
Journal Article, Clinical Trial, Comparative Study, Randomized Controlled Trial