Concomitant use of dexlansoprazole and other PPIs with Plavix: TGRD U.S. initiates trial
February 12, 2016
"The extent to which each PPI is metabolized by the liver enzyme CYP2C19 varies. Prior to the FDA approval of dexlansoprazole, Takeda conducted a variety of in vitro and clinical studies, which suggested that dexlansoprazole is not likely to inhibit the liver enzyme CYP2C19," said David Recker, M.D., senior vice president of clinical science for TGRD U.S. "This new study will provide clinicians with additional information regarding the interaction potential between dexlansoprazole, lansoprazole, esomeprazole, and omeprazole with clopidogrel bisulfate. It will also represent the first prospective data with dexlansoprazole and clopidogrel and add to the body of information on the concomitant use of several other PPIs and clopidogrel."
In the interaction study, subjects will be randomized into eight regimen sequence groups, each of which will receive two regimens. The endpoints of this study are to measure plasma concentrations of the active metabolite for clopidogrel and to determine the subject's total exposure to the active metabolite after clopidogrel has been administered with each of the PPIs for nine days. Platelet function will also be assessed prior to and during the trial, as well as 24 hours following the nine-day exposure to each PPI.
SOURCE Takeda Global Research & Development Center, Inc.