Taste and Palatability of Orfadin Suspension

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to verify that pediatric patients, especially those who are not old enough to swallow capsules, accept the taste and palatability of a new suspension.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swedish Orphan Biovitrum
• Treatments: Nitisinone

Criteria

Inclusion Criteria:

• Patients with HT-1 currently managed on Orfadin (nitisinone) capsules.

• Age from 1 month to less than 18 years.

• Signed informed consent.

Exclusion Criteria:

• Any medical condition which in the opinion of the investigator makes the subject unsuitable for inclusion.

• Enrollment in another concurrent clinical study, or intake of an investigational medicinal product (IMP), within one month prior to inclusion in this study.

• Foreseeable inability to cooperate with given instructions or study procedures.