Conditions: Healthy Volunteers
Keywords: Orfadin Nitisinone Bioequivalence Bioavailability
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 12
Healthy volunteers: yes

Brief summary:
The study is primarily being performed in order to demonstrate bioequivalence between the Orfadin (nitisinone) suspension and the marketed capsule formulation. The study will also contain a comparison of the bioavailability of the suspension given with food and on an empty stomach.

Detailed description:
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.

Arms:
arm 1: Orfadin capsules, single dose, 30 mg arm 2: Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL) arm 3: Orfadin suspension 4mg/mL, single dose 30 mg (7,5 mL)

Interventions: intervention 1: Nitisinone, capsule intervention 2: Nitisinone, suspension
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: