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Back to the forum  2018-06-25 17:56 CEST (UTC+2h)
Amira Gouda
Junior

Egypt,
2018-06-03 16:30

Posting: # 18845
Views: 390
 

 Bioequivalence study conditions [Design Issues]

Dears
Could you please advice me if the BE study for amoxicillin/clavulanic acid is done under fast or fed conditions with references please??
Thanks in advance
Amira


Edit: Category changed; see also this post #1. [Helmut]
Helmut
Hero
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Homepage
Vienna, Austria,
2018-06-03 19:47

@ Amira Gouda
Posting: # 18849
Views: 328
 

 Amoxicillin/clavulanic acid: if possible, avoid fasting state

Hi Amira!

» […] if the BE study for amoxicillin/clavulanic acid is done under fast or fed conditions with references please??

Please do you homework first (see also this post #3).

The FDA requires two studies (fasting & fed). IMHO, that’s not a good approach because you might face a lot of nasty GI-related AEs in fasting state.

IMHO, the EMA’s GL is better (Section 4.1.1):

For products where the SmPC recommends intake of the reference medicinal product only in fed state, the bioequivalence study should generally be conducted under fed conditions.

The SmPC:

Augmentin should be administered with a meal to minimise potential gastrointestinal intolerance.


In our studies we didn’t serve a high-fat high-calory meal but a light breakfast as a compromise (since fasting is considered more discriminatory).

Cheers,
Helmut Schütz
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