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RegisterDrug prophylaxis: BE trials in healthy volunteers [Study Performance]
Dear drchilkoti,
ethically this might be the right thing to do. Do it for the volunteers.
Co-medication that decreases nausea could be expected to affect AUC and/or Cmax (tmax) of the compound in question. Whether you prefer to call this an interaction or not, it is something that affects the PK, and this is a true joker. But I don't think this in itself would be too much of a problem.
In certain BE-studies with opioids, the protocol specifies co-admin. of an antagonist. Your case is similar from the ethics perspective. So in contrast to HS, I will vote in favour.
EM.
ethically this might be the right thing to do. Do it for the volunteers.
Co-medication that decreases nausea could be expected to affect AUC and/or Cmax (tmax) of the compound in question. Whether you prefer to call this an interaction or not, it is something that affects the PK, and this is a true joker. But I don't think this in itself would be too much of a problem.
In certain BE-studies with opioids, the protocol specifies co-admin. of an antagonist. Your case is similar from the ethics perspective. So in contrast to HS, I will vote in favour.
EM.
Complete thread:
- Drug prophylaxis: BE trials in healthy volunteers drchilkoti 2008-11-02 09:19
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Drug prophylaxis: PK interaction? Helmut 2008-11-02 18:26
- Drug prophylaxis: PK interaction? drchilkoti 2008-11-03 13:21
- Drug prophylaxis: BE trials in healthy volunteersElMaestro 2008-11-03 09:16
- Drug prophylaxis: PK interaction? Helmut 2008-11-02 18:26
Ing. Helmut Schütz