Amoxicillin/clavulanic acid: if possible, avoid fasting state [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2018-06-03 19:47 (916 d 05:04 ago) – Posting: # 18849
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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).

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Helmut Schütz

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