BE study Design for Ri­va­rox­aban 20 mg [Design Issues]

posted by Tricky TAB – Bangladesh, 2022-07-04 11:33 (40 d 03:35 ago) – Posting: # 23103
Views: 433

Hello!

The Design for Rivaroxaban 20 mg BE Study stated by US-FDA is as follows:

Single-dose, two-treatment, two-sequence, four-period, fully replicate crossover

Is it possible to go with Single-dose, two-treatment, two-sequence, two-period crossover study design?

Thank You!


Edit: Category changed; see also this post #1. Guidance linked. [Helmut]

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