## Fed (IBD) → fasting [General Statistics]

Helmut, thank you very much for the reply related to the adjustment of alpha, testing of fed vs. fasted, as well as the detailed sample size discussion with R code provided.

Can you please also provide feedback on one more scenario:

6-way crossover, with the following treatments A) tablet formulation #1 fasted, B) tablet formulation #2 fasted, C) capsule formulation fasted, D) tablet formulation #1 fed, E) tablet formulation #2 fed, F) capsule formulation fed.

Is there an approach that can be used to test only the first 3 treatments (all fasted) in an interim fashion, and contingent upon the results continue to test the final 3 treatments (all fed)? We are assuming a typical Latin Square such as:

A B C D E F

B C D E F A

C D E F A B

D E F A B C

E F A B C D

F A B C D E

To allow the proposed interim analysis (all fasted), is it possible to execute only the first necessary part of the Latin Square, such as:

A B C x x x

B C x x x A

C x x x A B

x x x A B C

x x A B C x

x A B C x x

With completion of the remaining parts (all fed) after the interim analysis:

x x x D E F

x x D E F x

x D E F x x

D E F x x x

x x A B C x

F x x x D E

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! [Ohlbe]

Can you please also provide feedback on one more scenario:

6-way crossover, with the following treatments A) tablet formulation #1 fasted, B) tablet formulation #2 fasted, C) capsule formulation fasted, D) tablet formulation #1 fed, E) tablet formulation #2 fed, F) capsule formulation fed.

Is there an approach that can be used to test only the first 3 treatments (all fasted) in an interim fashion, and contingent upon the results continue to test the final 3 treatments (all fed)? We are assuming a typical Latin Square such as:

A B C D E F

B C D E F A

C D E F A B

D E F A B C

E F A B C D

F A B C D E

To allow the proposed interim analysis (all fasted), is it possible to execute only the first necessary part of the Latin Square, such as:

A B C x x x

B C x x x A

C x x x A B

x x x A B C

x x A B C x

x A B C x x

With completion of the remaining parts (all fed) after the interim analysis:

x x x D E F

x x D E F x

x D E F x x

D E F x x x

x x A B C x

F x x x D E

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! [Ohlbe]

### Complete thread:

- higher order crossover methodology sweiner 2020-06-30 01:07 [General Statistics]
- All dosed subjects have to be analyzed Helmut 2020-06-30 12:19
- All dosed subjects have to be analyzed sweiner 2020-06-30 17:08
- All dosed subjects have to be analyzed sedhosen 2021-03-16 08:30
- All dosed subjects have to be analyzed Helmut 2021-03-16 16:00

- higher order crossover methodology Relaxation 2020-06-30 14:10
- higher order crossover methodology sweiner 2020-06-30 17:10
- higher order crossover methodology ElMaestro 2020-06-30 18:17
- Fed (IBD) → fasting Helmut 2020-07-01 11:14
- Fed (IBD) → fastingsweiner 2020-07-07 03:00

- Fed (IBD) → fasting Helmut 2020-07-01 11:14

- higher order crossover methodology ElMaestro 2020-06-30 18:17

- higher order crossover methodology sweiner 2020-06-30 17:10

- All dosed subjects have to be analyzed Helmut 2020-06-30 12:19