QBR111216

• Research type

  Research Study

• Full title

  A Double-Blind, Randomized, Placebo-Controlled Single Centre Study Designed to Evaluate the Tolerability and Pharmacokinetics of Various Titration Schedules Using the Modified Release Formulations of Prednisolone and Dipyridamole in Healthy Male and Female Subjects

• IRAS ID

  76068

• Sponsor organisation

  Zalicus Inc.

• Eudract number

  2011-000881-37

• Research summary

  Prednisolone is readily absorbed from the digestive tract. Prednisolone is licensed to treat inflammatory and allergic disorders and can be used to treat illnesses such as anaphylaxis (swelling of the neck and difficulty breathing in response to an allergic reaction), inflammatory bowel disease and severe eczema.Dipyridamole is licensed as an aid to anticoagulation for the prevention of blood clots associated with prosthetic heart valves. It has an anti clotting action based on its ability to modify aspects of platelet function, such as aggregation and adhesion, which are associated with the initiation of clot formation. Dipyridamole can also act to widen the blood vessels in the heart. Administration of prednisolone and dipyridamole together has been shown to improve the steroid hormone efficacy and reduce side effects. In this study the tolerability and the way prednisolone and dipyridamole are distributed in the blood when administered together will be assessed with the ultimate goal of producing a single combined treatment which would improve patient compliance through a simplified administration regime.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0069

• Date of REC Opinion

  7 Jun 2011

• REC opinion

  Further Information Favourable Opinion