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A study to evaluate the bioequivalence of Orfadin capsules 20 mg compared to Orfadin capsules 10 mg. An open-label, randomized, cross-over, single-dose study in healthy volunteers.

The primary purpose of the study is to investigate whether the new 20 mg capsule of Orfadin® (nitisinone) has a similar bioavailability in the body (gives the same concentration in the blood) as two of the marketed capsules of 10 mg. The secundary…

Bioequivalence of Orfadin suspension 4 mg/mL compared to Orfadin capsules 10 mg, and the effect of food on the bioavailability of the suspension.
An open-label, randomized, cross-over, single-dose study in healthy volunteers.

The primary objective of this study is to show bioequivalence between nitisinone oral suspension and nitisinone capsules.Secondary objectives of this study are:- To assess the effect of food on the bioavailability of nitisinone oral suspension.- To…