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I was hoping for an advice on glucose administration for a BE study
Whenever there is a need to give oral glucose routinely to all
subjects, to prevent hypoglycemia, is it acceptable to go with
glucose tablets instead of the solution?
It was suggested to give the glucose around the Cmax of the drug
instead of giving it with the drug administration. Should it probably
be administered with water then (assuming that a powder with water
would distribute more homogenously then peaces of chewed solid,
therefore standardizing the influence of the solid glucose on the
dissolution media of the stomach)? And if needed to be given before
the water restriction period ends, can it still be administered with
The reason it was suggested to administer tablets rather then a
solution was more pleasant taste and therefore more compliance
observed. I would really appreciate any input on the influence of
such a switch on BE assessment.
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I presume this trial is on a drug meant for treatment/control of
diabetes mellitus. Accordingly, I would suggest you to carry-out some
activities as under:
1. Write to the respective agency (FDA/EMEA/HC) on dosing
formalities. Usually, dosing is to be done with 20% glucose solution
(total vol=240 ml as usual)
2. for safety reasons, check for glucose levels definitely at tmax
and also before and after that.
3. Be sure you are mentioning this activity in informed consent and
4. For convenience, you can do glucose level testing alongwith sample
timepoints. In this case, after you withdraw blood and transfer it
into sample tube, you can use last few drops in the syringe to check
glucose using a glucometer by placing the blood drop(s) on the
5. In case glucose levels are low, you can provide glucose solution
of some pre-decided strength (my personal preference is for a
solution rather than glucose powder/tablet/crystals)
6. Usually, the effect of the drug will occur after the water
restriction period is over (see the cmax/tmax) and hence the glucose
can be given in solution form.
7. Remember the safety of ther subject is most important and glucose
must be closely monitored.
8. Very imp ---> the dissolution profile of drug will change in case
you are dosing with 20% glucose instead of water only, hence the in-
vitro dissolution tests have to be conducted accordingly.
You can get back to me for any clarifications
Dr. Gagandeep Singh
Domain Consulting Team
Cognizant Technology Solutions
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