Mei San
☆    

Malaysia,
2017-12-07 04:52
(2303 d 14:54 ago)

Posting: # 18038
Views: 3,237
 

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

Dear all,

Just wonder if multiple dose BE is required for omeprazole capsule?

As I'm aware of the EMA MR dosage BE guideline, only single dose fasting & single dose fed studies are required for delayed release multiple unit formulation.

However, some sponsors did perform the multiple dose studies as shown in public assessment report.

Kindly advise. Thanks!
Neve
☆    

India,
2017-12-07 08:52
(2303 d 10:54 ago)

(edited by Neve on 2017-12-07 10:41)
@ Mei San
Posting: # 18039
Views: 2,859
 

 Omeprazole Capsule Multiple Dose/Steady State BE Requirement

❝ Just wonder if multiple dose BE is required for omeprazole capsule?


Normally, Single dose fasting and fed studies are required.

❝ some sponsors did perform the multiple dose studies as shown in public assessment report.


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.
Relaxation
★    

Germany,
2017-12-07 16:50
(2303 d 02:56 ago)

@ Neve
Posting: # 18041
Views: 2,765
 

 Omeprazole Capsule Multiple Dose/Steady State BE Requirement

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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