Bioequivalence and Bioavailability Forum

Dear anonymous!

❝ I have some questions regarding a one-sequence, two-period drug-drug interaction study. Each subject is dosed with A in Perid 1 and A+B in Period 2.

Oops, that's a wrong design! PK interaction studies must be performed as a cross-over. Imagine a situation, where you have a 'true' period effect. In a cross-over study the treatment effect will not affected. In the paired design you suggested it is not possible to separate any period effect from the treatment effect!
BTW, don't forget that PK interaction studies are to be perfomed in steady state (FDA: recommended, EMEA: mandatory).

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