Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-12-13 15:44 CET (UTC+1h)
 
Mei San
Junior

Malaysia,
2017-12-07 03:52

Posting: # 18038
Views: 292
 

 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
Junior

India,
2017-12-07 07:52
(edited by Neve on 2017-12-07 10:41)

@ Mei San
Posting: # 18039
Views: 250
 

 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
Junior

Germany,
2017-12-07 15:50

@ Neve
Posting: # 18041
Views: 215
 

 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:.
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,556 Posts in 3,758 Threads, 1,089 registered users;
29 users online (0 registered, 29 guests).

The purpose of models is not to fit the data,
but to sharpen the questions.    Samuel Karlin

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed