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

posted by Neve – India, 2017-12-07 08:52 (3122 d 08:42 ago) – Posting: # 18039
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(edited on 2017-12-07 10:41)

❝ 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.

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