Bioequivalence and Bioavailability Forum

Dear All,

The guidance in FDA for metformin and some other anti diabetic drugs gives us the below information.

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.


Glucose administration is to avoid hypo glycemia related adverse events in healthy subjects

But Can any one please let me know why only 20% glucose? why only 60ml ? and why upto 4 hours?

thanks and regards,

KRISH

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Edit: Category changed. [Helmut]