Bioequivalence and Bioavailability Forum

Dears

I am working on fed and fasted studies for a bilayer drug containing empagliflozin/metformin XR. In the fed study, one volunteer showed no measurable concentration of empagliflozin for the test product, although a measurable concentration of metformin was observed in the same individual. The sponsor asserts that empagliflozin does not require a reliable concentration in the fed state since it is intended to be taken in the fasted state and is immediate-release, which would, in their view, negate the need for fed-state evaluation.

We attempted to include this subject in the statistical calculations; however, SAS and WinNonLin automatically excluded the subject due to the missing concentration for empagliflozin, resulting in a passed study.

As the CRO, we have raised concerns, viewing the lack of measurable concentration for empagliflozin in the fed state as a potential issue regarding product conformity. How can we configure the statistical software to include this subject in the analysis, potentially yielding a failed study outcome? Alternatively, what rationale could we provide in the study documentation to ensure regulatory acceptance of our approach and prevent potential questions for the CRO?.
Thanks in advance

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Edit: Category changed; see also this post #1. [Helmut]