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anky1212 ☆ India, 2016-12-27 15:50 (3008 d 12:42 ago) Posting: # 16884 Views: 6,629 |
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Hi all, Can anyone suggest which antiemetic shall be used to mitigate undesirable effect of Carbidopa, Levodopa and Entacapone tablets like nausea, vomiting in Bioequivalence study in normal human subjects? Please share antiemetic drug with reference. Thanks and regards, Anky |
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BE-proff ● 2016-12-27 16:08 (3008 d 12:24 ago) @ anky1212 Posting: # 16885 Views: 5,677 |
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Hi anky1212, I can see two options:
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anky1212 ☆ India, 2016-12-27 16:43 (3008 d 11:49 ago) @ BE-proff Posting: # 16886 Views: 5,634 |
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❝ I can see two options:
Thanks for reply. We are planning to enroll healthy human volunteer. My only concern is to use appropriate antiemetic drug which was used previously in trial/ BE study of LCE. Please suggest appropriately. Thanks |
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mittyri ★★ Russia, 2016-12-27 18:15 (3008 d 10:17 ago) @ anky1212 Posting: # 16887 Views: 5,678 |
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Dear anky1212, This question is not so easy to answer. The best way to control vomiting and nausea is peripheral dopamine receptor blocker like Domperidone or central blocker like Metoclopramide (also blocks central effects, but they aren't needed here, right?). By the way using these drugs you can change gastric/enteric motility and also bioavailability of drugs of interest. Please consider to review this paper I didn't find any data regarding active antiemetic therapy in BEQ studies for Stalevo. Maybe more experienced colleagues have more information... — Kind regards, Mittyri |
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anky1212 ☆ India, 2016-12-27 19:02 (3008 d 09:30 ago) @ mittyri Posting: # 16888 Views: 5,670 |
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Thanks mittyri for your reply. Since domperidone increases bioavailability, we may not use it for BE of LCE. Also, drugs which is dopamine antagonist may worsen pd symptoms and may not be used as antiemetic for BE OF LCE. Can we use ondansetron for BE of LCE to mitigate emesis, nausea? But i need reference for the same which i couldn't fimd. Please reply if anyone finds reference or any useful suggestion. 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 #5! [Helmut] |
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mittyri ★★ Russia, 2016-12-27 20:33 (3008 d 07:59 ago) @ anky1212 Posting: # 16890 Views: 5,718 |
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Dear anky1212, ❝ Also, drugs which is dopamine antagonist may worsen pd symptoms and may not be used as antiemetic for BE OF LCE. We are trying to prevent the dopamine-induced AE, right? Your subjects will be healthy, I suppose no PD in anamnesis. Due to the antagonism dopamine blockers are No1. I think metoclopramide would be even more effective due to the central effect, but not sure. ❝ Can we use ondansetron for BE of LCE to mitigate emesis, nausea? Yes, you can, but it would be not so effective as dopamine blockers. ❝ But i need reference for the same which i couldn't fimd. I think no one performed such a study (LCE/LCE+Ondansetron) due to lack of physiological basis of interaction. BTW ondansetron is mentioned as an antiemetic treatment in PD here and here — Kind regards, Mittyri |
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luvblooms ★★ India, 2016-12-28 09:05 (3007 d 19:27 ago) @ anky1212 Posting: # 16891 Views: 5,673 |
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Hi Anky ❝ ❝ Can anyone suggest which antiemetic shall be used to mitigate undesirable effect of Carbidopa, Levodopa and Entacapone tablets like nausea, vomiting in Bioequivalence study in normal human subjects? Not for the said combination but yes, many companies have used antiemetic drugs to counteract the nausea and vomiting observed with certain anticholinesterases. Details available at A Randomized, Crossover, Single-Dose Bioequivalence Study of Two Extended-Release Tablets of Donepezil 23 mg in Healthy Human Volunteers under Fasting and Fed States And product was approved by USFDA ❝ Please share antiemetic drug with reference. My suggestion, write to FDA before starting any study if you are doubtful. — ~A happy Soul~ |
Ing. Helmut Schütz