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suchit_bhavsar ★ India, 2013-06-25 13:06 (4339 d 03:39 ago) Posting: # 10874 Views: 6,458 |
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Hello to all of you.. At the time of dosing, if subject requesting for additional water to consume investigational product, can we provide the water ? Should we file protocol deviation for this ? Regards, Suchit Bhavsar  |
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Dr_Dan ★★ Germany, 2013-06-25 16:38 (4339 d 00:08 ago) @ suchit_bhavsar Posting: # 10876 Views: 5,509 |
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Dear Suchit Bhavsar Subjects need to be advised that they have to fast from at least 10 hours before until 4 hours after administration. During this fasting period beverages free of energy are allowed with the exeption of 30 minutes before until two hours after application. However, the administration takes place with 240 ml of water, so I see no reason why the subject should be so thirsty that he should drink an additional amount of any kind of beverage within 2 hours after administration. If he does it is a protocol deviation which has to be recorded. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Helmut ★★★   Vienna, Austria, 2013-06-25 17:56 (4338 d 22:49 ago) @ Dr_Dan Posting: # 10877 Views: 5,522 |
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Dear Dan & Suchit ❝ […] I see no reason why the subject should be so thirsty that he should drink an additional amount of any kind of beverage within 2 hours after administration. Since Suchit wrote ❝ […] subject requesting for additional water to consume investigational product I guess this was not a question of being thirsty. If the drug sticks to the esophagus it might play havoc to absorption. In such a case I would allow for some more water to make sure the drug reaches the stomach. ❝ If he does it is a protocol deviation which has to be recorded. Agree. — 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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Dr_Dan ★★ Germany, 2013-06-25 18:24 (4338 d 22:21 ago) @ Helmut Posting: # 10878 Views: 5,488 |
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❝ ❝ […] subject requesting for additional water to consume investigational product Ouuuups, I missed that. I personally never had the situation where a subject needed some more water..... — Kind regards and have a nice day Dr_Dan |
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suchit_bhavsar ★ India, 2013-06-26 07:20 (4338 d 09:25 ago) (edited on 2013-06-26 10:18) @ Helmut Posting: # 10881 Views: 5,426 |
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❝ I guess this was not a question of being thirsty. If the drug sticks to the esophagus it might play havoc to absorption. In such a case I would allow for some more water to make sure the drug reaches the stomach. Correct the case was like this only, subject was having trouble to swallow tablet as tablet was some what bigger Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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raghu ★ India, 2013-06-28 10:24 (4336 d 06:21 ago) @ suchit_bhavsar Posting: # 10895 Views: 5,401 |
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Dear All, If we give additional water during dosing to a single subject, will it affect the solubility of the product and subsequently on the absorption, pk and stats results. However it depends on the amount of water what we have given. If it occurs in P-I, can we give the same amount of additional water to the same subject in next period(s) to avoid variability. Can we drop the subject from the study, to avoid the queries from the regulatory. Regards Raghu |
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Helmut ★★★ Vienna, Austria, 2013-06-28 16:22 (4336 d 00:23 ago) @ raghu Posting: # 10900 Views: 5,489 |
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Dear Raghu, ❝ If we give additional water during dosing to a single subject, will it affect the solubility of the product and subsequently on the absorption, pk and stats results. However it depends on the amount of water what we have given. In fasted state such differences are unlikely. Non-caloric liquids are leaving the stomach within minutes (google for “Magenstrasse”). ❝ If it occurs in P-I, can we give the same amount of additional water to the same subject in next period(s) to avoid variability. If you want to minimize any potential difference you can do that. ❝ Can we drop the subject from the study, to avoid the queries from the regulatory. Wrong question. You should ask yourself whether there might be an impact based on scientific grounds. Anticipate such incidents and give a procedure to follow in the protocol. If you haven’t done so, consider performing a sensitivity analysis (with/without the subject) and discuss the potential impact on the BE assessment in the report. “Exlusion to avoid regulatory queries” IMHO is never a good justification. See this presentation by Werner Weitschies: Potential impact of excipients and size/shape of dosage form on GI transit — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz