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I would appreciate it if anyone who has experience with Alcohol interaction studies could provide further guidance to my question.
One approach to this study would be to use an IV ethanol clamp methodology in HVs; however, one of our colleagues had previous experience, and he suggested that the FDA recommend an oral alcohol paradigm as it accounts for the natural variability in alcohol kinetics and potential effects of alcohol on the absorption of the study drug. One of the reasons for using the ethanol clamp method is exactly that fact, to standardise the alcohol intake across all subjects.
I am unable to find if FDA (and also EMA) had issued any sort of guidance/paper/communication regarding the use of the methodology in alcohol interaction studies.
Any guidance would be much appreciated.