At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Single Dose, 5-period, 5-treatment, Crossover Study to Assess the Relative Bioavailability of 4 Different Formulations of Verinurad and Allopurinol in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Verinurad prolonged release HPMC capsule, Allopurinol Tablet, and 2 other interventions for Chronic Kidney Disease. Completed, enrolled 25 participants across 1 site.
Detailed Summary
This study is a single centre, randomised, open-label, single-dose, 5-period, 5-treatment, crossover study in healthy male and female subjects. This study is intended to assess the relative bioavailability between the fixed dose combination (FDC, i.e. verinurad/allopurinol FDC capsule 12/300 mg) and free combination formulations of verinurad (i.e. verinurad prolonged release Hydroxypropyl methylcellulose \[HPMC\] capsule 12 mg) and allopurinol (i.e. allopurinol table 300 mg) in fasted and fed conditions. The study will also assess the relative bioavailability between a formulation only containing verinurad (i.e. verinurad prolonged release gelatin capsule 12 mg) and the FDC capsule.
Study Details
Timeline
Interventions
Randomized subjects will receive oral dose of verinurad HPMC capsule.
Randomized subjects will receive oral dose of allopurinol tablet.
Randomized subjects will receive oral dose of Verinurad/Allopurinol FDC capsule.
Randomized subjects will receive oral dose of Verinurad gelatin capsule.