Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine

Sutphin Drugs

Status: Unknown

Conditions: Hereditary Tyrosinemia, Type I

Treatments: Drug: Nitisinone; Drug: Orfadin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04113772

Global CRO Orfadin

Details and patient eligibility

About

he purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product are bioequivalent to the reference product Orfadin 10 mg

Full 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.

Enrollment: 4 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Orfandin .5 mgm/kg mgm bid

Active Comparator group

Description:

Two participant will receive .5 mgm/kg mgm of orfadin

Treatment:

Drug: Orfadin

Nitinosine .5 mgm/kg bid

Experimental group

Description:

Two participant will receive .5 mgm/kg of nitinosine

Treatment:

Drug: Nitisinone