At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
Nitisinonedrug
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.
A Single Center, Single-Dose, Open-Label, Randomized Study to Compare the Bioavailability of an Oral Test Formulation Containing Nitisinone 10 mg in at Least 16 Healthy Male and Female Subjects Under Fasting and Fed Conditions
In Brief
A Phase 1 clinical trial evaluating Nitisinone for Hereditary Tyrosinemia, Type I. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The purpose of this study is to compare the bioavailability of the Test Product, Nitisinone 10 mg Tablet, under fasting and fed conditions (food-effect).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Tyrosinemia, Type I
CountriesSouth Africa
CollaboratorsParexel
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartNov 2015
Primary CompletionDec 2015
Study CompletionJan 2016
First PostedApr 2016
TodayJul 2026
First PostedApr 25, 2016
Enrollment StartNov 1, 2015
Primary CompletionDec 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 10.2 years ago
Interventions
Nitisinonedrug
A single oral dose of Nitisinone 10 mg Tablet will be administered.