North Macedonia,
2021-09-24 17:47
(996 d 12:12 ago)

Posting: # 22595
Views: 2,282

 EU: Fed or fasting conditions for BE study [Design Issues]

Dear all,

Please advise if the BE study for EU submission should be performed under fed or fast condition for the following case:

Fix dose combination product, for one mono-component of the FDC there is a product specific guideline in which it is recommended that the BE study should be performed under fasting condition, and for the second mono-component there is no product specific guideline.

According to the SmPC of the reference product (FDC) intended for the BE study it is stated: FDC should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with the second mono-component (for which we do not have product specific guideline).

For the first mono-component, co-administration of a high-fat meal has no effect on the pharmacokinetics, and this mono-component may be administered with or without food.

For the second mono-component for which we do not have product specific guideline, it is known that Food decreases the extent and slightly delays the absorption.

What is the most appropriate condition for performing the BE study in this situation, fed or fasting :-) ?

Thank you,


Edit: Category and subject line changed; see also this post #1 and #2[Helmut]
Vienna, Austria,
2021-09-24 18:07
(996 d 11:53 ago)

@ Farmacevt
Posting: # 22596
Views: 1,861

 EU: Fed state according to the reference’s SmPC

Hi BR,

❝ What is the most appropriate condition for performing the BE study in this situation, fed or fasting :-) ?

IMHO, in fed state. Justification:
  • The product-specific GL is not for a FDC and in general fasting is preferred. However, there is no food effect of the first mono-component.
  • Even if you would perform a study of the second component alone, according to the BE-GL it would have to be in fed state, since required in the reference’s SmPC. You don’t want to make the subjects :vomit:
Nevertheless, some (or most?) agencies may ask you for studies vs the mono-components (if marketed). See this post.

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North Macedonia,
2021-09-27 23:44
(993 d 06:16 ago)

@ Helmut
Posting: # 22603
Views: 1,760

 EU: Fed state according to the reference’s SmPC

Thank you very much for the replay Helmut.

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 #5[Helmut]
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