At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Nitisinone 20 mg +1 moredrug
Likely dose
Nitisinone 20 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 Study to Evaluate the Bioequivalence of Orfadin Capsules 20 mg Compared to Orfadin Capsules 10 mg. An Open-label, Randomized, Cross-over, Single-dose Study in Healthy Volunteers.
In Brief
A Phase 1 clinical trial evaluating Nitisinone 20 mg and Nitisinone 10 mg for Healthy. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg capsules in healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNetherlands
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2013
First PostedMay 2013
Primary CompletionJun 2013
TodayJul 2026
First PostedMay 20, 2013
Enrollment StartMay 1, 2013
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13.1 years ago
Interventions
Nitisinone 20 mgdrug
Nitisinone 20 mg capsules
Nitisinone 10 mgdrug
Nitisinone 10 mg capsules