Bioequivalence and Bioavailability Forum

Dear All,

I have a question regarding the choice of the comparator to be chosen in a classical CO study.

To summarize, my company get the marketing autorisation for a generic product (Tablet, called T1) based on a PK study demonstrating the bioequivalence versus the original product (called R).
Furthermore, according to the originator's SPC, the recommended dose is 1 or 2 Tablets.

Therefore, the R&D branch of my company would like to develop a new dosage of the product T1 corresponding to 2 tablets of the original product (R) in order to increase patients' comfort and compliance with the treatment (only quantitative change to the active substance). The new proposed dosage will be called T2.

Could you please advise which design should be better for a PK study:

• CO BE study; T2 versus original product R (2 tablets) or
  
• CO BE study; 2 Tablets of T1 vs T2 or
  
• Dose-proportional study; T1 vs T2

Hope it clear.....

Thank you in advance for your answer,