NCT04113772

Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine

Orfadin and Nitinosine Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (estimated)
• Sponsor: Sutphin Drugs · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Hereditary Tyrosinemia, Type I

Interventions

Type	Name	Description
DRUG	Nitisinone	Measure bio equivalency/efficacy of nitinosine and orfadin
DRUG	Orfadin	Orfadin

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-12-31
• Completion: 2021-03-31
• First posted: 2019-10-03
• Last updated: 2019-10-03

Locations

1 site across 1 country: India