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Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine

NCT04113772 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-10-03

No results posted yet for this study

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

Conditions

  • Hereditary Tyrosinemia, Type I

Interventions

DRUG

Nitisinone

Measure bio equivalency/efficacy of nitinosine and orfadin

DRUG

Orfadin

Orfadin

Sponsors & Collaborators

  • Sutphin Drugs

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-12-31
Completion
2021-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04113772 on ClinicalTrials.gov