Bioequivalence and Bioavailability Forum

Dear Members,

Thanks to the forum for accepting me as a member and the registration process was indeed very quick.

I would appreciate your views on a situation like

For one of the pilot studies on Metaxalone in Fed conditions versus Ref (Skelaxin) 800mg, for 50% of the volunteers we have observed steep increase in concentration at 16th and 24th hour timepoints (last sample at 72hrs) for both test as well as Ref product.16th and 24th hour samples were collected in-house

All the volunteers had consumed fed breakfast and nothing was leftover.

Such observations are very rare unless the product is known to be having two absorption phases (e.g Dexlansoprazole), but nothing reported for Metaxalone.

From the analytical perspective the samples were repeated and found to have similar concentration.

There was no mixup of the samples between volunteers at 16th and 24th hour.

Anything from formulation and or pharmacology perspective would help

Regards
Chirag

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Edit: Category changed. [Helmut]