Bioequivalence and Bioavailability Forum

Hello everybody!

It´s my first post in this forum although I frequently read yours when I have any BA/BE doubt, but this time I didn´t find similar posts.
Sorry for my English, I´ll do my best to express myself and my question clearly.

I´m monitoring a bioequivalence study in a CRO with which we have never worked before.
It´s a two‐period cross‐over study, in healthy subjects, in fasted conditions.

While verifying the source documents of period 1 (at this time the wash out period is running), I noticed that the investigation site was administering parenteral hydration to the subjects since the first sample (pre-dose) was collected and during about the next 12 hours. The administered volumes were different between subjects and went from 1000 to 2500 ml. In addition, the volunteers were able to drink water since 2 hrs after drug administration.

This procedure wasn’t established in the study protocol. So we asked the principal investigator (PI) about that practice, their reasons and possible impact on study (since we send him the question by email I don´t have any answer yet).

I´m concerned about this situation. I have doubts about the potential impact on the results of the study but I don´t have the tools to “scientifically” support “my doubts”….

Thinking in next period of the study, the PI and his team have at least to repeat exactly the same (volume, times, etc) parenteral hydration than in first period, to not increase intra subject variability?

Do you thing administering parenteral hydration is a good practice in a BE study? Could the results of PK parameters been affected? what about de BE conclusions?

I would really appreciate your opinions or similar experiences if you have!

Thank you very much in advance….

Regards!!

---

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