NCT01857362

Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nitisinone 20 mg	Nitisinone 20 mg capsules
DRUG	Nitisinone 10 mg	Nitisinone 10 mg capsules

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-05-20
• Last updated: 2021-10-12
• Results posted: 2014-10-27

Locations

1 site across 1 country: Netherlands