GREY:IPHAF - Post by User
Post by
stockman6on Nov 20, 2001 12:52pm
898 Views
Post# 4428156
Food Effect Study
Food Effect StudyThis was something I wasn't aware of. It's nice to see ISA concerned about the patients total comfort while administering a greatly improved drug.
Food Effect Study
In the Phase IA and IB trials, ISATX247 was administered as a single dose to fasting subjects. Having patients fast prior to every dose would be difficult and impractical. The effects of food on the absorption of ISATX247 were therefore investigated in 18 normal subjects.
The drug was administered in a fasting state, and compared to administration following a low fat and high fat breakfast. The results of this study indicated that food had no significant effect on the absorption of ISATX247; therefore, the drug may be administered to patients in either fasting or fed states, substantially simplifying the dosing regimen.