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

posted by drgunasakaran1  – 2021-08-06 10:47 (1018 d 00:34 ago) – Posting: # 22513
Views: 1,956

Dear Mr Prasad,

❝ 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?

Gliclazide falls under the category of NTI :confused: :confused:
As per the bioequivalence studies submitted to countries in EU Regions/EMA, most of the studies were conducted as two period, two way, cross over design for Gliclazide.

Reference 1: EU-procedure number: NL/H/1701/001/DC
Reference 2: DK/H/2376/001-002/DC
Reference 3: FR/H/171/02/DC
Reference 4: PL 42176/0005-06

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.

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