Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine

• Status: Unknown status
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

Summary

he purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product are bioequivalent to the reference product Orfadin 10 mg

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sutphin Drugs
• Treatments: Nitisinone

Criteria

Inclusion Criteria:

• All HT-1 patients receiving Orfadin treatment are eligible for entry.

• Male and female patients of all ages diagnosed with HT-1.

• Stable lab values, including liver values <2 ULN (ALP, ALT, AST, bilirubin, INR).

• Women of childbearing potential willing to use adequate contraception

• Signed informed consent/assent.

Exclusion Criteria:

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

• Enrollment in another concurrent clinical interventional study within three months prior to inclusion in this study.

• Pregnant women.

• Lactating women. .Known hepatitis B, hepatitis C or HIV infection.

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