Bioequivalence and Bioavailability Forum

Dear Madam/Sir,

I am currently planning a bioequivalence for our FDC product Ceftriaxone+Vancomcyin (Injection Formulation).

In this regard, I have few queries I would like to ask my forum memebers.

I am planning it as an open label, randomized, two treatment, two sequence, two period, single dose, cross over, comparative bioavailability study of FDC of Ceftriaxone+Vancomcyin and Rocephin^® (Innovator) of Hoffmann – La Roche Inc., France & XXX (containing vancomycin) of ABC in 24+4 normal healthy, adult, human subjects under fasting conditions.

Is this study design seems fine or else what better design I can put in ?

What is the innovator product for Vancomycin?

Is the sample size is correct ?

FDC (test) product will be reconstituted with normal saline and administered through a peripheral venous catheter and the Reference products (each separately) will be reconstituted with normal saline separately and both of them were infused simultaneously through a dual line peripheral venous catheter.

Am doing it right?

What type of bioanalytical methods HPLC or LC-MS/MS preferable?

Please suggest.

Thanks and regards,

Raghav