What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKG [Regulatives / Guidelines]

posted by prasad.v – India, 2021-07-29 10:33 (181 d 23:08 ago) – Posting: # 22486
Views: 1,750

Dear All,

Little bit confusion raised as the Gliclazide is a NTI molecule, what would be the study design for gliclazide 80mg tablet BE study for Europe, WHO & HKG submission.
  1. Can we do the two-way crossover or full replicate fast and fed by widening AUC?
  2. Can we do the two-way crossover or full replicate fast and fed by widening AUC and Cmax?

Regards,
V. Prasad

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