mmw
☆    

India,
2015-02-12 08:56
(3333 d 01:55 ago)

Posting: # 14409
Views: 4,930
 

 Metformin BE study [Design Issues]

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According to the FDA draft guidance of Metformin, "The drug products should be administered with 240 mL of a 20% glucose solution in water, followed by 60 mL of the glucose solution administered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
mmw
☆    

India,
2015-02-18 09:25
(3327 d 01:26 ago)

@ mmw
Posting: # 14452
Views: 3,958
 

 Metformin BE study

Dear all,

Expecting your view on this.

Thanks

MMW


Edit: Relax and read the Forum’s Policy in the meantime. Six days two weeks. [Helmut]
krish85
☆    

India,
2015-02-24 07:54
(3321 d 02:57 ago)

@ mmw
Posting: # 14496
Views: 3,854
 

 Metformin BE study

Dear,

Greetings !!

I think the nausea and vomiting concern will be in fed study only.

In that case, glucose water can be given as and when required ... No need to put it as mandatory in protocol.

As per safety criteria, you will be monitoring RBS upto 4 hour time point (or as required , upto tmax) after dosing.

if RBS goes below to the specified limut,than as per physician discretion, glucose water can be given to those volunteer Only.

Hope i clarified your concern !


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
mmw
☆    

India,
2015-02-24 10:50
(3321 d 00:01 ago)

@ krish85
Posting: # 14497
Views: 3,880
 

 Metformin BE study

Dear Krish,

Thanks for your response!

❝ As per safety criteria, you will be monitoring RBS upto 4 hour time point (or as required , upto tmax) after dosing.


❝ if RBS goes below to the specified limut,than as per physician discretion, glucose water can be given to those volunteer Only.


We followed the same procedure of monitoring the RBS till Tmax and those who reported low RBS were administered the glucose solution.


Thanks

MMW
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