Omeprazole Capsule Multiple Dose/Steady State BE Requirement [Design Issues]
❝ 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
- Omeprazole Capsule Multiple Dose/Steady State BE RequirementNeve 2017-12-07 07:52