Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients
Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
Participant gender:
Summary
The study is being conducted to evaluate the pharmacokinetic parameters (Cmax, Tmax and AUC)
of the new delayed release, lowered dose, 40 mg 6MP test formulation as compared to standard
6MP (100 mg Purinethol) in 12 patients with Crohn's Disease.
The study is being undertaken to prove that the new test formulation is indeed
delayed-release and targeted to the ileum, and that the levels of 6MP in the blood following
local absorption are lower than that seen following standard Purinethol dosing. This should
result in lower, safer mercaptopurine dosing, allowing for uninterrupted treatment with fewer
side effects.