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

Healthy Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT01857362
• Study type: Interventional
• Source: Swedish Orphan Biovitrum
• Status: Completed
• Phase: Phase 1
• Start date: May 2013
• Completion date: June 2013