multiple dose studies [Design Issues]

posted by dshah  – India/United Kingdom, 2024-03-08 18:36 (100 d 11:13 ago) – Posting: # 23895
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Hello Loky do!


❝ I have a solifenacin succinate/tamsulosin HCl bioequivalence study, I will perform a multiple-dose study for tamsulosin modified release for Europe, I'm a little confused about the planned washout for this study as there are no enough public assessment reports for the combination, should I take in account the solifenacin washout period also or to design on tamsulosin only is enough (i.e one-week washout between 2 periods from last dose)


As this is FDC- both the drug needs to be analyzed and thus also consider Solifenacin for washout consideration.

Regards,
Divyen

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