Omeprazole Capsule Multiple Dose/Steady State BE Requirement [Design Issues]

posted by Relaxation  – Germany, 2017-12-07 16:50 (1938 d 15:43 ago) – Posting: # 18041
Views: 2,620

Hello everybody.

Just a short input as I do not fully agree with the answer.

❝ Normally, Single dose fasting and fed studies are required.

Would be my answer, too.

❝ Reason may be, omeprazole has time-dependent kinetics (omeprazole auto-inhibits its metabolism). ❝ Hence, according to Guidance on the investigation of Bioavailability and Bioequivalence, a

❝ steady state study is required due to this time dependency.

Would it be possible to point to the guideline you are referring and maybe the page? I mean, I could follow that argument if the task was to clarify the pharmacokinetics of a product.
But in case of bioequivalence I fail to understand the need for a study at steady-state (and also fail to find that requirement in the guidelines I am aware of).

OK, if this was a prolonged release formulation, but, um, do such formulations for omeprazole exist :confused:.

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