Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine (NCT04113772) | Clinical Trial Compass
UnknownNot Applicable
Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine
India4 participantsStarted 2019-11-01
Plain-language 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
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.