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Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1)

NCT02750345 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-06-14

Study results available
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Summary

The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1) and Nitisinone 10 mg Tablets 'Baked' for 6 months @ 40°C/75% RH (Test Product 2) are bioequivalent to the reference product Orfadin 10 mg hard capsules.

Conditions

  • Hereditary Tyrosinemia, Type I

Interventions

DRUG

Nitisinone

A single oral dose of Nitisinone 10 mg Tablet will be administered.

DRUG

Nitisinone Baked Tablet

A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.

DRUG

Orfadin

A single oral dose of Orfadin 10 mg hard capsule will be administered.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Cycle Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • André Nell · +27 51 410 3046

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • South Africa

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 NCT02750345 on ClinicalTrials.gov