PPIs sometimes highly variable even in fasted state [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2017-02-27 12:32 (2911 d 07:29 ago) – Posting: # 17113
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Dear Dan and M.tareq,

❝ the design for the fed state study does not need to be the same as for the fasted study.


Agree.

❝ In fact it would be unethical to treat more subjects in the fasted study in a more elaborated design than you would need to demonstrate bioequivalence.


When it comes to PPIs I only partly agree. There are no safety concerns (in some contries some PPIs are even available OTC). Sometimes PPIs show a CVwR >30% even in fasted state. IMHO, I could make sense to design both studies in a replicate design – though the sample size could be different.

❝ ❝ i.e partial replicate ?


The partial replicate is lousy design (search the forum…). See this post why a 4-period full replicate is preferable over 3-period replicates.

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