Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension

This is an open, randomized 3-way crossover study in 12 healthy volunteers. Subjects will receive single oral 30-mg doses of nitisinone as a suspension (fasting and with food) and as hard gelatin capsules (fasting only). There will be a 2-week washout period between the doses.

There will be a screening visit within 3 weeks prior to the first dose. During each treatment period, subjects will be admitted to the clinic from the afternoon on the day before drug administration (i.e., on Day -1) and remain at the clinic until the 48-hour post-dose blood sample has been collected in the morning of Day 3. They will then return for ambulatory visit in the morning of Day 4 (72-hour sample). A follow-up visit will take place 7-14 days after the last dose.

Inclusion criteria

• Healthy male volunteers
• Age: 18-55 years, inclusive
• BMI: 18,5-30,0 kg/m2, inclusive

Exclusion criteria

• heavy smokers
• Consumption of more than 4 cups of coffee per day.
• History of drug and/or alcohol abuse.
• Positive drug screen or alcohol breath test.
• Positive screens for hepatitis B surface antigen, hepatitis C antibodies and human immunodeficiency virus (HIV) 1-2 antibodies.
• Enrollment in another concurrent clinical study
• Intake of an investigational medicinal product within three months prior to inclusion in this study.
• Donation of more than 50 mL of blood within 60 days prior to drug administration
• Donation of more than 1,5 liters of blood in the 10 months prior to first drug administration.