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

posted by drgunasakaran1  – 2021-08-06 08:47 (289 d 12:41 ago) – Posting: # 22513
Views: 1,386

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.

Complete thread:

UA Flag
Activity
 Admin contact
22,091 posts in 4,630 threads, 1,566 registered users;
online 6 (0 registered, 6 guests [including 5 identified bots]).
Forum time: Sunday 21:29 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5