Bioequivalence and Bioavailability Forum

Dear All,

Please clarify,

For “Esomeprazole Gastro Resistant Capsules 40 mg and 20 mg” what are the studies required for Europe?

As a normal practice crossover fasting and fed studies on 40 mg and fasting study on 20 mg is sufficient?

Need to conduct “multiple dose study on 40 mg” and “single dose fasting study on 20 mg”?

Here reference product is “Esomeprazole Gastro Resistant Tablets 40 mg and 20 mg”, since innovator capsules are not available in Europe market.

Regards
Kotu.