DEERFIELD, Ill., Feb. 9 /PRNewswire/ -- Takeda Global Research & Development Center, Inc., U.S., (TGRD U.S.) announced today that it has initiated a trial to study how dexlansoprazole and several other proton pump inhibitors (PPIs) affect the pharmacokinetics and pharmacodynamics of Plavix (clopidogrel bisulfate) in healthy subjects. Takeda has been evaluating all published data and communications from the U.S. Food and Drug Administration (FDA) regarding the potential risks associated with concomitant use of clopidogrel and PPIs.
According to a recent FDA announcement, studies have shown that omeprazole inhibits a liver enzyme (CYP2C19) important for the activation of clopidogrel. With CYP2C19 inhibition, clopidogrel will have reduced anticlotting effects, thereby reducing its effectiveness. The FDA has recommended that co-administration of omeprazole and other potent CYP2C19 inhibitors, including esomeprazole, be avoided in patients taking clopidogrel. It is unknown how other PPIs may interfere with Plavix.
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.
Important Safety Information
KAPIDEX is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity and anaphylaxis have been reported with KAPIDEX use. Symptomatic response with KAPIDEX does not preclude the presence of gastric malignancy.
KAPIDEX may interfere with the absorption of drugs for which gastric pH is important for bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole). Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Concomitant tacrolimus use may increase tacrolimus whole blood concentrations.
Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.
Takeda Global Research & Development Center, Inc.
