Metformin BE study [Design Issues]

posted by krish85 – India, 2015-02-24 07:54 (4141 d 03:28 ago) – Posting: # 14496
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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]

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