Completed PHASE1 INTERVENTIONAL 6-arm NCT02750345

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

A Three-Period Crossover Study to Determine the Bioequivalence of Two Oral Formulations Containing Nitisinone 10 mg Compared to Reference Formulation Orfadin In Healthy Subjects Under Fasting Conditions

Sponsor: Cycle Pharmaceuticals Ltd.

Conditions Hereditary Tyrosinemia, Type I

Interventions Nitisinone Nitisinone Baked Tablet Orfadin

Updated 6 times since 2017 Last updated: May 22, 2017 Started: Mar 31, 2016 Primary completion: May 31, 2016 Completion: May 31, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02750345, this PHASE1 trial focuses on Hereditary Tyrosinemia, Type I and remains completed. Sponsored by Cycle Pharmaceuticals Ltd., it has been updated 6 times since 2016, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Mar 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Cycle Pharmaceuticals Ltd.
Parexel

Data source: Cycle Pharmaceuticals Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Bloemfontein, South Africa