Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
2006-4-24
pubmed:abstractText
Prasugrel (CS-747, LY640315), a novel thienopyridine, is a potent and orally active antiplatelet agent in vivo. The aims of this double-blind, double-dummy, placebo-controlled, randomized, parallel group phase 1 study were to investigate the antiplatelet effects of prasugrel after oral administration of a loading dose (LD) and subsequent 20 days of once-daily maintenance dosing (MD), to characterize the pharmacokinetics of prasugrel metabolites with an LD/MD regimen, and to assess the safety and tolerability of prasugrel in healthy subjects. Subjects were randomly assigned in a 1:1:1 ratio to prasugrel 40 mg LD/7.5 mg MD (n = 11), prasugrel 60 mg LD/15 mg MD (n = 10), or placebo LD/placebo MD (n = 11). Prasugrel 40 and 60 mg LDs provided rapid and consistent inhibition of 20 microM adenosine diphosphate (ADP)-stimulated platelet aggregation. Prasugrel 7.5 and 15 mg MDs maintained inhibition in a dose-dependent manner. The pharmacokinetic data indicate that exposure to prasugrel metabolites occurs rapidly after dosing and is consistent with dose proportionality. Within the limitations of this study, the safety and tolerability results suggest that prasugrel is well tolerated when dosed as an initial LD followed by a lower daily MD for 20 days. Prasugrel LDs and MDs provide rapid and sustained inhibition of ADP-mediated platelet aggregation.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Mar
pubmed:issn
0160-2446
pubmed:author
pubmed:issnType
Print
pubmed:volume
47
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
377-84
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed:year
2006
pubmed:articleTitle
The platelet inhibitory effects and pharmacokinetics of prasugrel after administration of loading and maintenance doses in healthy subjects.
pubmed:affiliation
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA. joseph@lilly.com
pubmed:publicationType
Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't