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

Brief summary:
The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg capsules in healthy volunteers.

Detailed description:
This is an open, randomized 2-way crossover study in 12 healthy volunteers. Subjects will receive single oral 20 mg doses of nitisinone administrated as one 20 mg capsule or as two 10 mg capsules of Orfadin. There will be a 3-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: Two nitisinone 10 mg capsules by mouth as a single dose arm 2: One nitisinone 20 mg capsule by mouth as a single dose

Interventions: intervention 1: Nitisinone 20 mg intervention 2: Nitisinone 10 mg
Intervention descriptions: intervention 1: Nitisinone 20 mg capsules intervention 2: Nitisinone 10 mg capsules

Protocol document: