NK
☆    

India,
2023-01-23 10:38
(516 d 03:52 ago)

Posting: # 23431
Views: 2,551
 

 Study Design: Two treatment or Four treatment [Design Issues]

Hello Everyone,

We are planning a BE study with four arms (Test product under fasting, Test product under fed, Reference under fasting & Reference under fed) with two treatments (test and Reference). In this case, please clarify the study title to be mentioned as "Two treatment, Two sequence" or "Four treatment, two sequence" Bioequivalence study?
Kindly suggest any reference.

Regards
NK
dshah
★★  

India/United Kingdom,
2023-01-23 11:43
(516 d 02:46 ago)

@ NK
Posting: # 23432
Views: 2,117
 

 Study Design: Two treatment or Four treatment

Dear NK!

How are you going to access the BE? Are you comparing Test fasting vs Ref fasting/Ref Fed/ Test fed and similar or it is only Test fast vs Ref Fast, Test fed vs Ref fed?

Regards,
Divyen
NK
☆    

India,
2023-01-24 04:37
(515 d 09:53 ago)

@ dshah
Posting: # 23436
Views: 2,060
 

 Study Design: Two treatment or Four treatment

❝ How are you going to access the BE? Are you comparing Test fasting vs Ref fasting/Ref Fed/ Test fed and similar or it is only Test fast vs Ref Fast, Test fed vs Ref fed?


Hi Divyen,

In this case we will be comparing Test fast vs Ref Fast, Test fed vs Ref fed.

Similarly, in other scenario three arm study (Test fast, Ref Fast and Ref fed) with two treatments (Test and Reference) comparing Test fast vs Ref Fast, Test fed vs Ref fast. what will be appropriate treatment ( Two treatment or three treatment) to be mentioned in the title of the study.

Regards
NK


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]
ElMaestro
★★★

Denmark,
2023-01-23 16:05
(515 d 22:24 ago)

@ NK
Posting: # 23434
Views: 2,053
 

 Study Design: Two treatment or Four treatment

Hi NK

❝ We are planning a BE study with four arms (Test product under fasting, Test product under fed, Reference under fasting & Reference under fed) with two treatments (test and Reference). In this case, please clarify the study title to be mentioned as "Two treatment, Two sequence" or "Four treatment, two sequence" Bioequivalence study?


You can call it something like "a two-treatment, two-period, two-sequence randomised BE study in two cohorts (fed and fasted) to investigate similarity in rate and extent of absorption of Blahblah vs Blahblahblah in healthy adult volunteers."

Pass or fail!
ElMaestro
Relaxation
★    

Germany,
2023-01-23 17:10
(515 d 21:20 ago)

@ ElMaestro
Posting: # 23435
Views: 2,114
 

 Study Design: Two treatment or Four treatment

Hi everybody and ElMaestro.

I thought quite similarly and would use very similar terms.
But re-reading the OP, I have the feeling that the intention may be different and include 4 treatments (?).
For example, sequences could be
A) Test fed - Reference fed - Test fasted - Reference fasted
B) Reference fed - Test fed - Reference fasted - Test fasted.

I have seen such a proposal before (although we were allowed to then "mix" it up and used 4 sequences in the end to also allow assessment of the food effect).

So this would be "a 4 treatment, 2 sequence, 4 period, trial comprising fasted and fed administration" or something similar here.
Or one starts to get creative with "combined 2x2x2 cross-over blocks of fed and fasted adminstration" or something more fitting.
I have no reference for this, its just our house standard to consider each combination of product and administration condition (fed/fast, SD/MD) to be a separate treatment.


Best regards,
Relaxation.
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