Loky do
★    

Egypt,
2024-03-04 11:27
(39 d 04:21 ago)

Posting: # 23892
Views: 722
 

 multiple dose studies [Design Issues]

Dears

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)

thanks in advance


Edit: Category changed; see also this post #1[Helmut]
dshah
★★  

India/United Kingdom,
2024-03-08 18:36
(34 d 21:12 ago)

@ Loky do
Posting: # 23895
Views: 519
 

 multiple dose studies

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
Loky do
★    

Egypt,
2024-03-11 12:20
(32 d 03:28 ago)

@ dshah
Posting: # 23900
Views: 482
 

 multiple dose studies

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

I'm a little confused :confused: why to analyze solifenacin as it is immediate release and the concern towards tamsulosin as it is the delayed release one, even if I took into consideration the washout of both, are the results of solifenacin, in this case, affect those of tamsulosin?

Regards,
Loky


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]
dshah
★★  

India/United Kingdom,
2024-03-12 18:37
(30 d 21:11 ago)

@ Loky do
Posting: # 23905
Views: 432
 

 multiple dose studies

Hello Loky do!

❝ I'm a little confused :confused: why to analyze solifenacin as it is immediate release and the concern towards tamsulosin as it is the delayed release one, even if I took into consideration the washout of both, are the results of solifenacin, in this case, affect those of tamsulosin?


Kindly refer section 3 of EMA guideline on FDC.
[image]

Considering as a sponsor, the analysis of solifenacin adds a cost. But as a regulator- if you are taking the sample- why it is not analyzed? Any SE relation with PK would not be feasible, then.

Regards,
Divyen
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