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Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin

NCT02750709 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-03-15

Study results available
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Summary

The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1 (TP1)) and Nitisinone 10 mg Tablets High Compritol (Test Product 2 (TP2)) are bioequivalent to the reference product Orfadin 10 mg capsules.

Conditions

  • Hereditary Tyrosinemia, Type I

Interventions

DRUG

Nitisinone

A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.

DRUG

Nitisinone 10 mg Tablet High Compritol

A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.

DRUG

Orfadin

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

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Cycle Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • André Nell · Bloemfontein Early Phase Clinical Unit, PAREXEL Internation (South Africa)

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
2015-10-31
Primary Completion
2015-12-31
Completion
2016-01-31

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 NCT02750709 on ClinicalTrials.gov