Bioequivalence and Bioavailability Forum

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

posted by drgunasakaran1  – 2021-08-06 10:47 (546 d 07:26 ago) – Posting: # 22513
Views: 1,580

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
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

Complete thread:

• What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKG prasad.v 2021-07-29 10:33 [Regulatives / Guidelines] 
  • No acceptance criteria widening for AUC in Europe vixen 2021-07-30 18:44
  • No reference-scaling for NTIDs Helmut 2021-08-02 14:57
  • What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKGdrgunasakaran1 2021-08-06 08:47