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Terminée
objectif
A phase I, randomized, open-label, crossover study to evaluate the antiplatelet effect of intravenous clopidogrel (MDCO-157) versus oral clopidogrel
date de réalisation
2012
nombre de patients
33
nombre de centres participants
Monocentrique (Pitié-Salpêtrière)
type de financement
Privé (The Medicines Company)
Référence
NCT01860105
Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Open-label, Randomized, Cross-over Evaluation (AMPHORE)
Following a first, dose ascending study that enrolled 144 normal healthy volunteers (NHVs), this study, to be conducted in approximately 36 NHVs, will provide pertinent information in determining the dose-response of MDCO-157 for platelet aggregation inhibition and P2Y12 receptor inhibition effects and in selection of doses that match the antiplatelet effects of 300 mg PLAVIX® ®. The study will also provide additional data for pharmacokinetics (PK), safety and tolerability of single doses of MDCO-157.
source clinicaltrials.gov
Publication
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