Good luck :-) [PK / PD]

posted by VijithRoy – India, 2020-07-31 05:48 (260 d 17:32 ago) – Posting: # 21811
Views: 1,528

»
» I can't tell from the info you have given what type of study you are doing, but I think you are saying you are comparing two insulins. It sounds like a BE study.
» In that case you are taking blood samples every now and then, probably after the subjects have been given the insulin as an s.c. injection. In these blood samples you measure insulin levels.

Exactly what you said is correct.

our study comparing two insulin products (T/R), two period cross over study with 14 subjects.

Primary parameter - AUC, Cmax (PK) and GIR, GIRmax (PD)
Seconday parameters - ADR, Blood, urine sample test ect,.

10hr fasting before dosing and complete 24hr fasting after dosing till end time point.

nearly 219 blood samples for PD analysis (YSI) and 24 blood (plasma)samples for PK analysis.
Predose collection will be done for 3 samples.

So this is the study goes for each clamp.

With Best Regards,
Vroy.

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