Posting: # 18761
Can anyone please confirm, for (generic) Cefixime tablets, do we need to submit both, Fasting and Fed BE studies in Canada?
As far as i know, we submit Fasting studies for most of the products (uncomplicated IR products) in Canada.
However, somewhere on google, i found an article stating that Cefixime has non-linear kinetics. Therefore, i am not sure if we need to conduct both fasting and fed or only fasting will be fine.
A quick response is really desired.
Edit: Relax; see also this post #9. Please don’t shout! [Helmut]
Posting: # 18762
As per canadian guidelines the fasting and fed study was required for only modified formulations. So, I think we can go with fasting study and I was checked literature i didnt find any non-linear things in kinetics. So, my suggestion is fasting study.
Edit: Full quote removed (as in all of your replies so far: first warning). Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
(edited by Ohlbe on 2018-05-17 10:08)
Posting: # 18772
Thanks a Lot Lakshmiprasad...
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Posting: # 18773
» As per canadian guidelines the fasting and fed study was required for only modified formulations.
It still is! Comparative Bioavailability Standards: Formulations Used for Systemic Effects, Section 184.108.40.206 (2012):
Requirements for modified-release dosage forms differ from those for immediate-release formulations because a greater likelihood exists that increased inter-subject variability in bioavailability will occur, including the possibility of dose-dumping. There may also be an increased risk of adverse effects such as gastrointestinal irritation, depending on the site of drug release, or absorption, or both. Hence, for all modified-release dosage forms (including delayed-release formulations), bioequivalence should be demonstrated under both fasted and fed conditions.
» So, I think we can go with fasting study …
Correct, since the tablets are IR.
» … and I was checked literature i didnt find any non-linear things in kinetics.
Maybe you should improve your skills in literature research.1–5
Click here ⇒ or there ⇒ Google Scholar
HC’s guidance, section 220.127.116.11:
For drugs with non-linear pharmacokinetics in the single unit dose range of approved strengths due to saturable absorption and resulting in less than proportional increases in AUC with increasing dose, the comparative bioavailability study should be conducted on at least the lowest strength (single dose unit).
The quality of responses received is directly proportional to the quality of the question asked. ☼