Bioequivalence and Bioavailability Forum • Omeprazole Capsule Multiple Dose/Steady State BE Requirement

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

posted by Neve – India, 2017-12-07 08:52 (1937 d 22:05 ago) – Posting: # 18039
Views: 2,716
(edited by Neve 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.

Complete thread:

Omeprazole Capsule Multiple Dose/Steady State BE Requirement Mei San 2017-12-07 03:52 [Design Issues]
- Omeprazole Capsule Multiple Dose/Steady State BE RequirementNeve 2017-12-07 07:52
  - Omeprazole Capsule Multiple Dose/Steady State BE Requirement Relaxation 2017-12-07 15:50