Bioequivalence and Bioavailability Forum

Dear Luise
If co-administration of 20% glucose solution in order to reduce potential AEs in healthy volunteers has an effect on absorption of the drug, does this matter? If you are interested just in bioavailability this might be a question but if you refer to bioequivalence you should keep in mind that th co-administration would only affect the solubilized drug, the comparison of test and reference formulation would not be affected. The purpose of bioequivalence studies is to detect possible impact of different formulations on the pharmacokinetics of the investigated drug and if both formulations are administered the same way everything is fine since absorption is a characteristic of the drug substance itself and is unaffected by formulation.
I hope this helps
Kind regards
Dan