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drchilkoti ☆ India, 2008-11-02 10:19 (6092 d 02:26 ago) Posting: # 2615 Views: 6,949 |
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Role of drug prophylaxis in prevention of adverse events in bioequivalence trials in healthy volunteers? Can one administer i.v granisetron for prevention of Nausea/vomiting in bioequivalence trial evaluating antidepresant or antipsychotics as granisetron is known to have no effect on gastrointestinal motility if adinistered i.v. Thanks & Regards, Deepak -- Edit: category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2008-11-02 19:26 (6091 d 17:18 ago) @ drchilkoti Posting: # 2616 Views: 5,915 |
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Dear Depak, I wouldn't do that, unless you have strong evidence that your drug does not show any pharmacokinetic interactions with granisetron. As a starter have a look at drugs.com. For a justification you must dig the original references. Remember: absence of evidence is not evidence of absence. I would go for a scientific advice and/or a talk with the ethics committee in the planning stage of the study. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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drchilkoti ☆ India, 2008-11-03 14:21 (6090 d 22:23 ago) @ Helmut Posting: # 2618 Views: 5,469 |
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Dear Both, Thanks for the reply. My other concern was safety (after ruling out p/k interaction). I want to know how one will be able to differentiate that a particular adverse event is because of study mediction or due to prophylactic drug. Finally, Is such study data acceptable by regulatory authorities because i came across no examples of such studies during my search on internet. Thanks & Regards, Deepak -- Edit: Full quote removed. Please see this post! [Jaime] |
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ElMaestro ★★★ Denmark, 2008-11-03 10:16 (6091 d 02:28 ago) @ drchilkoti Posting: # 2617 Views: 5,404 |
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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. |
Ing. Helmut Schütz