Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine

Hereditary Tyrosinemia, Type I Clinical Trial

— Orfadin  

Official title:

Orfadin and Nitinosine Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04113772
• Other study ID #: Global CRO Orfadin
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: October 2019
• Source: Sutphin Drugs
• Contact: Ajai Prakash
• Phone: 7185260310
• Email: ajaiprakashny[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 evaluate the in vivo performance of two formulations of Nitisinone 10 mg and the reference product Orfadin under fasting.

A total of 4 healthy female and male volunteers (age 18 to 55 years old) will be entered into the study. Volunteers will be determined to be free of significant medical conditions as assessed by medical history, physical examination, and blood and urine tests. Volunteers will be randomly allocated to a treatment sequence, before administration of investigational nitinosine

Determination of succinylacetone (SA) in blood (serum/plasma) and/or urine will be performed. Results from samples analyzed at the central laboratory, including determination of nitisinone, will be used in the evaluation of pharmacokinetics, efficacy and safety during the two treatment periods.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hereditary Tyrosinemia, Type I
• Tyrosinemias

Intervention

Drug:
• Nitisinone
Measure bio equivalency/efficacy of nitinosine and orfadin
• Orfadin
Orfadin

Locations

Country	Name	City	State
India	Lifein Multi-Specialty Hospital	Navsari	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Sutphin Drugs

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Succinylacetone level	Succinylacetone level will be measured every 2 weeks for eight weeks	8 weeks