Bioequivalence and Bioavailability Forum

Dear All,

We are planning to conduct a single dose, four-treatment, four-period, two-sequence, crossover comparative bioavailability study on Fixed dose combination, of two molecules having different Tmax and AUC. This requires large number of sample collection time points resulting in more blood loss. To avoid large amount of blood loss I would like to know if we could conduct two different studies in which the investigational product would be the FDC and concentration of one the either molecule would be measured and considered for assessment of bioequivalence in each study. Would the combined data of the two studies be accepted to demonstrate the bioequivalenc of the FDC?

Regards,

Anju