Hereditary Tyrosinemia, Type I Clinical Trial
Official title:
Orfadin and Nitinosine Study
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:
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.
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