Regarding Insulin Clamp study [PK / PD]

posted by VijithRoy – India, 2021-06-27 06:49 (115 d 11:22 ago) – Posting: # 22435
Views: 580

Hello all,

I currently work on Insulin clamp BE study. It's a two period cross over double blinded study. Recently, i noticed the Glucose infusion rate (GIR) vs time (hr) graph of one subject which reflected the neat graph (i.e, on set of action was in range), where as the period II of the same subject showed zero GIR or onset of action was out of the normal range. The same case I found in more than 2 subject.

If in case of treatment effect(A/B), I also noticed both (A/B) gave proper Tmax &Cmax for other subjects.

What might be the possible reasons (eg_intrasubject variation, T/R, formulation etc,.) for
Significant no action in GIR compared to period 1?

Thanks,
Vijit.

With Best Regards,
Vroy.

Complete thread:

Activity
 Admin contact
21,749 posts in 4,547 threads, 1,544 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Wednesday 18:11 CEST (Europe/Vienna)

Mediocrity finds safety in standardization.    Frederick E. Crane

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