Bioequivalence and Bioavailability Forum • Omeprazole, widen of Cmax in a normal crossover design?

Omeprazole, widen of Cmax in a normal crossover design? [Design Issues]

posted by wienui – Germany/Oman, 2016-04-07 13:00 (3729 d 19:29 ago) – Posting: # 16169
Views: 9,003

❝ ❝ “The primary pharmacokinetic variables evaluated for single dose studies were AUC0-t and Cmax and for steady state, AUCτ and Cmax. Bioequivalence was determined based on limits of 80-125% for AUC and 70-143% for Cmax.”

Dear All,

Could we widen the Cmax rang to 70-143% of HVD (Omeprazole) in a normal (not a replicate) 2x2 crossover BE study.

Thanks,

—
Cheers,
Osama

Complete thread:

Omeprazole joyjac 2012-05-15 09:22
- Omeprazole drgunasakaran1 2012-05-15 09:50
  - Omeprazole Helmut 2012-05-15 19:00
    - Omeprazole pash413 2012-12-06 18:09
      - Cmax at tlast Helmut 2012-12-07 15:29
    - Omeprazole, widen of Cmax in a normal crossover design?wienui 2016-04-07 11:00
      - Omeprazole reference = HVDP Helmut 2016-04-07 12:57