Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine
NCT ID: NCT04113772
Last Updated: 2019-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
4 participants
INTERVENTIONAL
2019-11-01
2021-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Orfandin .5 mgm/kg mgm bid
Two participant will receive .5 mgm/kg mgm of orfadin
Orfadin
Orfadin
Nitinosine .5 mgm/kg bid
Two participant will receive .5 mgm/kg of nitinosine
Nitisinone
Measure bio equivalency/efficacy of nitinosine and orfadin
Interventions
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Nitisinone
Measure bio equivalency/efficacy of nitinosine and orfadin
Orfadin
Orfadin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Sutphin Drugs
INDUSTRY
Responsible Party
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Locations
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Lifein Multi-Specialty Hospital
Navsari, Gujarat, India
Countries
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Central Contacts
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Other Identifiers
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Global CRO Orfadin
Identifier Type: -
Identifier Source: org_study_id
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