Bioequivalence and Bioavailability Forum

Hi dixit,

❝ Mobiflex is rapidly and completely absorbed as unchanged drug. Concomitant food reduces the rate, but not the extent, of absorption of Mobiflex.

I would assume that it essentially means the PK is affected by food (Cmax, but apparently not AUC). A food study, hence, is likely a necessity.

Dear Dixit,

My take is a little different from ElMaestro.

The EMA guideline states the following:

"For products where the SmPC recommends intake of the reference medicinal product on an empty stomach or
irrespective of food intake, the bioequivalence study should hence be conducted under fasting conditions."

This is what the UK SPC for Mobiflex says:

A single daily dose of 20mg Mobiflex should be taken orally, at the same time each day. Mobiflex Tablets are for oral administration with water or other fluid.

There is no mention of food anywhere in the posology. Therefore, my opinion is that only a single fasting study is needed as "In general, a bioequivalence study should be conducted under fasting conditions as this is considered to be the most sensitive condition to detect a potential difference between formulations."

Anyone else see it this way (or not)?

Thanks,
Torn

Dear Dixit:

I am totally agreed with the recommendation of stated by Torn by EMEA for the fed study "For products where the SmPC recommends intake of the reference medicinal product on an empty stomach or irrespective of food intake, the bioequivalence study should hence be conducted under fasting conditions".
As per my experiences the fed study is not required for EMEA only when there is a statement in the Posology that the drug can be taken with or without food.
Since in the SPC of the Mobiflex this statement is not present and in the pharmacokinetics it has been clearly mentioned that the “Concomitant food reduces the rate, but not the extent, of absorption of Mobiflex”.
So as per my opinion you have to perform both the fasting and fed study.

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