Bioequivalence and Bioavailability Forum

Hi,

Anyone has issues running glyburide studies for FDA in terms of the glucose solution supplement to prevent hyopglycemia in Indian CROs? As per FDA draft guidance, 60 mL of 20% glucose solution needs to be administered every 15 minutes post dose for up to 4 hrs. Drug is to be given with 240 mL of 20% glucose solution.

A few PIs whom I contacted have issues with this because of frequent osmotic diarrhea (like 3 - 6x) within Tmax. They preferred to deviate from the FDA guidance and not give the glucose solution on a pre-determined interval. Instead they will give glucose solution on a needed basis.

I ran glyburide studies in US and Canada in the past and never had this problem. I did see some diarrhea events but not as severe as what those PIs claimed to experience.

Okay, osomtic diarrhea can happen if subjects are exposed to large amount of sugar and salt.

Any suggestions?

Thanks
John