CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Nitisinone +2 moredrug
Likely dose
Nitisinone 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02750345
NCT02750345Phase 1Completed
CompareCT.gov

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

Cycle Pharmaceuticals Ltd.·interventional·Posted Apr 25, 2016·Updated Jun 14, 2017

In Brief

A Phase 1 clinical trial evaluating Nitisinone, Nitisinone Baked Tablet, and 1 other intervention for Hereditary Tyrosinemia, Type I. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Tyrosinemia, Type I
CountriesSouth Africa
CollaboratorsParexel

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 25, 2016
Enrollment StartMar 1, 2016
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.2 years ago

Interventions

Nitisinonedrug

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

Nitisinone Baked Tabletdrug

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

Orfadindrug

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