Bioequivalence and Bioavailability Forum • multiple dose studies

Loky do
★

Egypt,
2024-03-04 11:27
(435 d 02:50 ago)

Posting: # 23892
Views: 3,736

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,
2024-03-08 18:36
(430 d 19:41 ago)

@ Loky do
Posting: # 23895
Views: 2,827

multiple dose studies

Post reply

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
(428 d 01:57 ago)

@ dshah
Posting: # 23900
Views: 2,836

multiple dose studies

Post reply

❝ 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,
2024-03-12 18:37
(426 d 19:41 ago)

@ Loky do
Posting: # 23905
Views: 2,729

multiple dose studies

Post reply

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