Status:
UNKNOWN
Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine
Lead Sponsor:
Sutphin Drugs
Conditions:
Hereditary Tyrosinemia, Type I
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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
Detailed Description
Detailed Description: The specific aim is to conduct a randomized, single dose, three-period crossover bioequivalence study in at least 18 healthy male and female subjects at a single study center to...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04113772
Start Date
November 1 2019
End Date
March 31 2021
Last Update
October 3 2019
Active Locations (1)
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1
Lifein Multi-Specialty Hospital
Navsari, Gujarat, India, 396421