Bioequivalence and Bioavailability Forum

Dear All,

According to the FDA draft guidance of Metformin, "The drug products should be administered with 240 mL of a 20% glucose solution in water, followed by 60 mL of the glucose solution administered every 15 minutes for up to 4 hours after dosing."

However, during Metformin fed BE study it is found that number of subjects experienced nausea and vomiting and it may be due to heavy load of glucose water after high fat breakfast and dosing.

We experienced same cases of vomiting during fasting study also. Number of dropouts resulted in less number of subjects in hand to conclude BE.

Question is :- Is it necessary to give glucose water post-dose as Metformin alone does not cause hypoglycemia? or is their any alternative process we can follow? (e.g. Frequent blood glucose monitoring in first hours till Tmax).

Thanks

MMW